QSL Package Worksheet MS-2407-42 KNEE SLEEVES COMPRESSION.xlsx

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Knee Sleeves, Compression
Solicitation number
MS-2407-42
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This is a Qualified Suppliers Listing (QSL) Package Worksheet for Knee Sleeves, Compression, solicitation MS-2407-42, issued by the Defense Health Agency and Defense Logistics Agency Troop Support Medical. The solicitation seeks to establish a Qualified Suppliers Listing for compression knee sleeves in eight specific sizes and configurations (open and closed patella, small to XL), with an estimated annual sales volume of $471,847. Vendors must meet extensive technical requirements, including providing FDA-registered medical devices not made with natural rubber latex, demonstrating proper packaging and labeling, and having agreements with prime vendors Cardinal Health and Owens & Minor.

Key response dates include a vendor response deadline of 5:00 PM local Philadelphia time on 03 April 2025, with vendor notification of QSL qualification by approximately 24 April 2025. Participating vendors must have an active System for Award Management (SAM) account, a DAPA (Distribution and Pricing Agreement) number, and provide comprehensive product documentation. The resulting Incentive Agreement will not guarantee specific sales volume, and all items must be manufactured in Trade Agreements Act (TAA) compliant countries. Only vendors offering US-made, designated country, or qualifying country end products will be considered for the Incentive Agreement, unless no functional equivalent is available from a compliant source.

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QSL Package Worksheet

Requirements to Qualify for the QSLMS-2407-42 KNEE SLEEVES, COMPRESSION
Company Name:
Company Address:
Company Point of Contact (POC):

Name Phone Number

E-Mail AddressComplete answers and all supporting documentation must be provided with the vendor’s submittal by the response date stated in the QSL Announcement, Sources Sought notification. A vendor who does not meet all these requirements, or who does not submit documentation to support these requirements as requested, will not be qualified for the QSL. Vendors must provide responses to the Sources Sought notification via this QSL Package Worksheet.
****PLEASE READ THE FOLLOWING BEFORE CONTINUING WITH YOUR SUBMISSION BELOW***

Product requirements are outlined below. Complete answers and all supporting documentation MUST be provided with the vendor’s submittal by the response date stated in the Sources Sought notification. A vendor who does not meet all of these requirements or who does not submit documentation to support these requirements as requested will not be qualified for the QSL. Vendor must provide responses to the Sources Sought notification via the QSL Package Worksheet.

SUPPLIER REQUIREMENTS
VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" ENTER YOUR DAPA NUMBER OR THE DATE YOU APPLIED FOR A DAPA ALONG WITH DAPA LOG NUMBER.

1. Vendor must have a DAPA or be in the process of applying for a DAPA number for the product line listed. Vendor must provide their DAPA number or provide date of application and DMM number proving access to the DMS, as the subsequent Standardization Action requires vendors to have all required items on DAPA.VENDOR RESPONSE:
VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" ENTER

YES - IF YOU HAVE AN AGREEMENT

OR

NO - IF YOU DO NOT HAVE AN AGREEMENT AND INDICATE THAT YOU ARE WORKING WITH PRIME VENDOR TO INITIATE AN AGREEMENT.

2. Vendor must have an agreement with the current DoD Medical/Surgical Prime Vendor CARDINAL HEALTH, or must work with CARDINAL HEALTH to initiate an agreement, as standardized items from this QSL will be distributed via the MSPV program.VENDOR RESPONSE:
3. Vendor must have an agreement with the current DoD Medical/Surgical Prime Vendor OWENS & MINOR, or must work with OWENS & MINOR to initiate an agreement, as standardized items from this QSL will be distributed via the MSPV program.VENDOR RESPONSE:
VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" ENTER YOUR CAGE CODE OR THE DATE YOU APPLIED FOR A CAGE CODE ALONG WITH THE CURRENT STATUS.

4. Vendors must validate that their account is Active in the System for Award Management (SAM) and provide CAGE Code. Vendors in the process of obtaining a CAGE Code must provide documentation to support that they have registered in SAM. Vendors without a CAGE Code and/or a SAM account will not be considered for participation in the subsequent Standardization Action. See https://www.sam.gov/SAM/.VENDOR RESPONSE:
REQUIRED PRODUCTS
VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" for EACH REQUIRED ITEM IDENTIFY SUPPORTING DOCUMENTATION(S) (i.e. catalogs, brochures, website screen shots with date, product pictures, packaging pictures, etc.). WITHIN DOCUMENTATION, ANNOTATE SECTION(S) THAT SUPPORT SPECIFIC REQUIREMENT.

5. Vendor must provide manufacturer part numbers that meet the product descriptions below. Vendor must submit the following information via QSL Response Worksheet for each offered product: Vendor Part Number, Manufacturer Part Number, Manufacturer Name, Full Item Description, Unit of Measure (UOM), Quantity (QTY) in UOM, Unit of Inner Packaging (UOP), QTY of UOM in UOP, Unit of Sale (UOS), and QTY of UOM in UOS. Vendor must provide product catalog and literature for any items offered in response to this Sources Sought notification. Only ONE Vendor Part Number should be provided for each item/sample. Vendor must send the same reference number(s) for evaluation(s) as provided in response to this QSL Announcement and as noted in the QSL Package Worksheet. The vendor must provide country of origin for all required items and any optional items offered.
Required Product DescriptionEstimated DoD Purchase UnitsManufacturer's Product DescriptionManufacturer Part NumberDistributor Part NumberManufacturer NameUnit of Measure (UOM)QTY in UOMUnit of Inner Packaging (UOP)QTY of UOM in UOPUnit of Sale (UOS)QTY of UOM in UOSProduct Country of OriginVendor Response
E.g. 0 12-18in COATED VICRYL VIO BRD TIESZ123-ABC123ABCCOMPANY AEA1PK12CA24USASee Product Catalog pg. 109
5.1 COMPRESSION KNEE SLEEVE, OPEN PATELLA, LEFT AND RIGHT KNEE USE, SMALL, ( 15-17 ½” ) CIRCUMFERENCE3,300
5.2 COMPRESSION KNEE SLEEVE, OPEN PATELLA, LEFT AND RIGHT KNEE USE, MEDIUM, ( 18 - 20" ) CIRCUMFERENCE6,990
5.3 COMPRESSION KNEE SLEEVE, OPEN PATELLA, LEFT AND RIGHT KNEE USE, LARGE, ( 20 ½ -23” ) CIRCUMFERENCE7,369
5.4 COMPRESSION KNEE SLEEVE, OPEN PATELLA, LEFT AND RIGHT KNEE USE, XL, ( 23 ½ -25 1/6” ) CIRCUMFERENCE1,716
5.5 COMPRESSION KNEE SLEEVE, CLOSED PATELLA, LEFT AND RIGHT KNEE USE, SMALL, ( 15-17 ½” ) CIRCUMFERENCE3,056
5.6 COMPRESSION KNEE SLEEVE, CLOSED PATELLA, LEFT AND RIGHT KNEE USE, MEDIUM, ( 18 - 20" ) CIRCUMFERENCE1,232
5.7 COMPRESSION KNEE SLEEVE, CLOSED PATELLA, LEFT AND RIGHT KNEE USE, LARGE, ( 20 ½ -23” ) CIRCUMFERENCE3,488
5.8 COMPRESSION KNEE SLEEVE, CLOSED PATELLA, LEFT AND RIGHT KNEE USE, XL, ( 23 ½ -25 1/6” ) CIRCUMFERENCE310
PRODUCT SPECIFIC REQUIREMENTS - TECHNICAL REVIEW
VENDOR INSTRUCTIONS

UNDER "VENDOR RESPONSE" IDENTIFY SUPPORTING DOCUMENTATION(S) (i.e. catalogs, brochures, website screen shots with date, product pictures, packaging pictures, etc.). WITHIN DOCUMENTATION, ANNOTATE SECTION(S) THAT SUPPORT SPECIFIC REQUIREMENT.

E.g. See ENCL 3 - Suture + Ties Reels Memo Natural Rubber Latex

6. Vendor must provide Compression Knee Sleeve products that are not made with natural rubber latex. Vendor must also provide submittal documentation establishing that the offered products are not made with natural rubber latex. The vendor must meet this requirement in one of three ways: 1) demonstrating that the labeling or product information for the offered products contains the FDA recommended statement "Not made with natural rubber latex," 2) demonstrating that the ISO BS EN 15223-1:2021 symbol [reference number 5.4.5 with Annex B.2 Negation Symbol] is on the labeling or product information for the offered products, or 3) if the labeling or product information do not contain the FDA recommended statement or the ISO BS EN 15223-1:2021 symbol [reference number 5.4.5 with Annex B.2 Negation Symbol], the vendor must provide a signed letter stating that the offered products are "not made with natural rubber latex.1Vendor must provide Compression Knee Sleeve products that are not made with natural rubber latex. Vendor must also provide submittal documentation establishing that the offered products are not made with natural rubber latex. The vendor must meet this requirement in one of three ways: 1) demonstrating that the labeling or product information for the offered products contains the FDA recommended statement "Not made with natural rubber latex," 2) demonstrating that the ISO BS EN 15223-1:2021 symbol [reference number 5.4.5 with Annex B.2 Negation Symbol] is on the labeling or product information for the offered products, or 3) if the labeling or product information do not contain the FDA recommended statement or the ISO BS EN 15223-1:2021 symbol [reference number 5.4.5 with Annex B.2 Negation Symbol], the vendor must provide a signed letter stating that the offered products are "not made with natural rubber latex.611VENDOR RESPONSE:
7. Vendor must provide Knee Sleeves Compression products that meet FDA General Controls and Special Controls as applicable and must submit supporting documentation with initial submittal to include FDA Establishment Registration, Medical Device listing, and 510(k) as applicable.2Vendor must provide Knee Sleeves Compression products that meet FDA General Controls and Special Controls as applicable and must submit supporting documentation with initial submittal to include FDA Establishment Registration, Medical Device listing, and 510(k) as applicable.712VENDOR RESPONSE:
8. Vendor must provide Knee Sleeve Compression products with measurements that fit the required product groupings measuring 5 - 8 inches ( “ ) above the mid-patella and provide documentation to support this with initial submittal.3Vendor must provide Knee Sleeve Compression products with measurements that fit the required product groupings measuring 5 - 8 inches ( “ ) above the mid-patella and provide documentation to support this with initial submittal.813VENDOR RESPONSE:
9. Vendor must provide Knee Sleeve Compression that can be donned as a pull-on item and provide documentation to support this with initial submittal.4Vendor must provide Knee Sleeve Compression that can be donned as a pull-on item and provide documentation to support this with initial submittal.914VENDOR RESPONSE:
10. Vendor must provide Knee Sleeve Compression products that include product cleaning instructions with each item and provide documentation to support this with initial submittal.5Vendor must provide Knee Sleeve Compression products that include product cleaning instructions with each item and provide documentation to support this with initial submittal.1015VENDOR RESPONSE:
VENDOR INSTRUCTIONS

In support of requirement 11, vendor must provide with initial submittal a photographic image for product’s individual packaging (front and back) of a Compression Knee Sleeve, Open Patella and a Compression Knee Sleeve, Closed Patella and provide a letter of attestation stating the other required items meet the requirement.

11. Vendor must provide Knee Sleeve Compression products with individual packaging that includes the following information:
a.Product Size (Small, Medium, Large, XL)
b.Instructions for Use (IFU) provided by either a product insert, QR Code, or printed on packaging.
c.Identification that the product is designed for left AND right knee use or exclusively for left OR right knee use only.
d.Part Number.6Vendor must provide Knee Sleeve Compression products with individual packaging that includes the following information:
a.Product Size (Small, Medium, Large, XL)
b.Instructions for Use (IFU) provided by either a product insert, QR Code, or printed on packaging.
c.Identification that the product is designed for left AND right knee use or exclusively for left OR right knee use only.
d.Part Number.11In support of requirement 11, vendor must provide with initial submittal a photographic image for product’s individual packaging (front and back) of a Compression Knee Sleeve, Open Patella and a Compression Knee Sleeve, Closed Patella and provide a letter of attestation stating the other required items meet the requirement.16VENDOR RESPONSE:
VENDOR INSTRUCTIONS

Vendor MAY provide any or all of the additional items listed below following the same format as for Requirement number 5.

Vendor must provide a letter of attestation, INCLUDING a list of part numbers for the submitted optional items, stating that the offered products meet all requirements after requirement 6.

Item DescriptionsEstimated DoD Purchase UnitsManufacturer's Product DescriptionManufacturer Part NumberDistributor Part NumberManufacturer NameUnit of Measure (UOM)QTY in UOMUnit of Inner Packaging (UOP)QTY of UOM in UOPUnit of Sale (UOS)QTY of UOM in UOSProduct Country of OriginVendor Response
E.g. 0 12-18in COATED VICRYL VIO BRD TIESZ123-ABC123ABCCOMPANY AEA1PK12CA24USASee Product Catalog pg. 109
1. COMPRESSION KNEE SLEEVE, CLOSED PATELLA, LEFT KNEE, MEDIUM, ( 18-20” ) CIRCUMFERENCE
2. COMPRESSION KNEE SLEEVE, CLOSED PATELLA, LEFT KNEE, LARGE, ( 20 ½ -23” ) CIRCUMFERENCE
3. COMPRESSION KNEE SLEEVE, CLOSED PATELLA, LEFT KNEE, XL, ( 23 ½ -25 1/6” ) CIRCUMFERENCE
4. COMPRESSION KNEE SLEEVE, CLOSED PATELLA, RIGHT KNEE, SMALL ( 15-17 ½” ) CIRCUMFERENCE
5. COMPRESSION KNEE SLEEVE, CLOSED PATELLA, RIGHT KNEE, MEDIUM ( 18 -20” ) CIRCUMFERENCE
6. COMPRESSION KNEE SLEEVE, CLOSED PATELLA, RIGHT KNEE, LARGE ( 20 ½ -23” ) CIRCUMFERENCE

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