Vendor Name - QSL Package Worksheet MD-2203-77 LARYNGOSCOPE BLADES AND HANDLES SINGLE USE.xlsx
XLSX spreadsheet 20 KB Posted
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- Laryngoscope Blades and Handles, Single Use
- Solicitation number
- MD-2203-77
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| File | Type | Posted |
|---|---|---|
| QSL Announcement MD-2203-77 Laryngoscope Blades and Handles. Single Use.docx | DOCX document |
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QSL Package Worksheet
| Requirements to Qualify for the QSL | MD-2203-77 LARYNGOSCOPE BLADES AND HANDLES, SINGLE USE |
| Company Name: |
| Dilley, Harold E CTR/DHA MEDLOG: Complete 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 of 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. | Company Address: |
| Company Point of Contact (POC): |
Name Phone Number E-Mail Address
****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 (PN), Manufacturer PN, 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. The vendor must provide country of origin for all required items and any optional items offered. Vendor must provide product catalog & literature for any items offered in response to this Sources Sought notification. Only ONE Vendor Part Number (PN) should be provided for each item/sample. Vendor must send the same part number(s) for evaluation(s) as provided in response to this QSL Announcement and as noted in the QSL Package Worksheet. | |||||||||||||
| Required Product Description | Estimated DoD Purchase Units | Manufacturer's Product Description | Manufacturer Part Number | Distributor Part Number | Manufacturer Name | Unit of Measure (UOM) | QTY in UOM | Unit of Inner Packaging (UOP) | QTY of UOM in UOP | Unit of Sale (UOS) | QTY of UOM in UOS | Product Country of Origin | Vendor Response |
| E.g. 0 12-18in COATED VICRYL VIO BRD TIES | Z123-ABC | 123ABC | COMPANY A | EA | 1 | PK | 12 | CA | 24 | USA | See Product Catalog pg. 109 | ||
| 5.1 LARYNGOSCOPE, BLADE, STAINLESS STEEL, SINGLE USE, MACINTOSH, SIZE 1, FIBER OPTIC | 171 | ||||||||||||
| 5.2 LARYNGOSCOPE, BLADE, STAINLESS STEEL, SINGLE USE, MACINTOSH, SIZE 2, FIBER OPTIC | 1,351 | ||||||||||||
| 5.3 LARYNGOSCOPE, BLADE, STAINLESS STEEL, SINGLE USE, MACINTOSH, SIZE 3, FIBER OPTIC | 10,949 | ||||||||||||
| 5.4 LARYNGOSCOPE, BLADE, STAINLESS STEEL, SINGLE USE, MACINTOSH, SIZE 4, FIBER OPTIC | 7,712 | ||||||||||||
| 5.5 LARYNGOSCOPE, BLADE, STAINLESS STEEL, SINGLE USE, MILLER, SIZE 0, FIBER OPTIC | 831 | ||||||||||||
| 5.6 LARYNGOSCOPE, BLADE, STAINLESS STEEL, SINGLE USE, MILLER, SIZE 1, FIBER OPTIC | 570 | ||||||||||||
| 5.7 LARYNGOSCOPE, BLADE, STAINLESS STEEL, SINGLE USE, MILLER, SIZE 2, FIBER OPTIC | 3,864 | ||||||||||||
| 5.8 LARYNGOSCOPE, BLADE, STAINLESS STEEL, SINGLE USE, MILLER, SIZE 3, FIBER OPTIC | 821 | ||||||||||||
| 5.9 LARYNGOSCOPE, BLADE, STAINLESS STEEL, SINGLE USE, MILLER, SIZE 4, FIBER OPTIC | 220 | ||||||||||||
| 5.10 LARYNGOSCOPE, HANDLE, SINGLE USE, MEDIUM/STANDARD , FIBER OPTIC | 10,380 | ||||||||||||
| 5.11 LARYNGOSCOPE, HANDLE, SINGLE USE, PENLIGHT/PEDIATRIC/SMALL/MINI, FIBER OPTIC | 960 | ||||||||||||
| 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 Laryngoscope Blades and Handles, Single Use 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." | 6 | Vendor must provide Laryngoscope Blades and Handles, Single Use 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." | 6 | 16 | VENDOR RESPONSE: |
| 7. Vendor must provide Laryngoscope Blades and Handles, Single Use products intended to be used for direct laryngoscopy and provide documentation to support this with initial submittal. | VENDOR RESPONSE: | ||||
| 8. Vendor must provide Laryngoscope Blades and Handles, Single Use products that conform to ISO 7376:2020 standards and provide documentation to support this with initial submittal. | VENDOR RESPONSE: | ||||
| 9. Vendor must provide Laryngoscope Handles, Single Use products that have a light level greater than 500 lux with a maximum illuminance duration >10 minutes and provide documentation to support this with initial submittal. | VENDOR RESPONSE: | ||||
| VENDOR INSTRUCTIONS |
Vendors must provide with initial submittal photographic images of the individual product packaging for each required item in support of requirement 10. Photographic images of non-part number graphic templates of product labeling are not acceptable supporting documentation.
10. Vendor must provide Laryngoscope Blades and Handles, Single Use products in individual packaging that includes the following information:
a. Lot number as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 lot symbol.
b. Single-use as indicated in a statement or with the appropriate ISO BS EN ISO 15223-1:2021 single-use symbol.
c. Type of blade (i.e., Macintosh or Miller) as indicated in a statement.
| d. Size of blade and handle as indicated in a statement. | VENDOR RESPONSE: | |
| PRODUCT SPECIFIC REQUIREMENTS - TECHNICAL REVIEW WITH PRODUCT SAMPLE VALIDATION | ||
| VENDOR INSTRUCTIONS |
Vendor Instructions: In support of requirements 11-14, vendor must provide with initial submittal a signed letter of attestation, INCLUDING a list of part numbers for 5.1, 5.2, 5.4, 5.5, 5.6, 5.8, and 5.9 required items, stating that the offered products meet requirements 11-14 and are manufactured in the same manner as the sample products for required items 5.3, 5.7, and 5.10.
11. Vendor’s provided Laryngoscope Blades and Handles, Single Use products must be interchangeable (i.e., from the same manufacturer). Vendor must provide product samples to support this with initial submittal. TRACKING NUMBER:
Shipping date:
Carrier:
| 12. Vendor must provide Laryngoscope Blades, Single Use products that have smooth edges over all surfaces (e.g., no burrs, cracks, nor disruptions on the product’s surface.) Vendor must provide product samples with initial submittal for tactile examination of the product surface. |
| 13. Vendor must provide Laryngoscope Handles, Single Use products with a self-contained battery or provide a ready-to-use battery in the same package as the handle. Vendor must provide product samples to support this with initial submittal. |
| 14. Vendor must provide Laryngoscope Handles, Single Use products with a textured surface or non-slip grip. Vendor must provide product samples to support this with initial submittal. |
| 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 Descriptions | Estimated DoD Purchase Units | Manufacturer's Product Description | Manufacturer Part Number | Distributor Part Number | Manufacturer Name | Unit of Measure (UOM) | QTY in UOM | Unit of Inner Packaging (UOP) | QTY of UOM in UOP | Unit of Sale (UOS) | QTY of UOM in UOS | Product Country of Origin | Vendor Response |
| E.g. 0 12-18in COATED VICRYL VIO BRD TIES | Z123-ABC | 123ABC | COMPANY A | EA | 1 | PK | 12 | CA | 24 | USA | See Product Catalog pg. 109 | ||
| 1. LARYNGOSCOPE, BLADE, STAINLESS STEEL, SINGLE USE, MACINTOSH, SIZE 0, FIBER OPTIC | |||||||||||||
| 2. LARYNGOSCOPE, HANDLE, SINGLE USE, STUBBY, FIBER OPTIC |
File details come from the government source that posted it. Updated .