FSL 2 Packaging Specifications - Commerical Specifications.pdf
PDF 365 KB Posted
- Attached to
- SOURCES SOUGHT: FreeStyle Libre 2 Sensor Kits Federal contract opportunity
- Solicitation number
- IHS1489027
About this file
This document contains a sources sought notice issued by the Navajo Area Indian Health Service, Pinon Health Center for FreeStyle Libre 2 Sensor Kits. The notice seeks potential suppliers to provide FreeStyle Libre 2 Sensor Kits for delivery to Pinon Health Center within 30 days of order receipt. Interested parties are requested to submit responses by the specified closing date demonstrating their capability and experience supplying similar medical products, geographic coverage, references, ability to meet specifications, and delivery logistics. Responses must include company information, point of contact, and a capability statement addressing qualifications and ability to provide the requirements. The notice does not obligate the government to award a contract, and any information provided by industry is strictly voluntary and will not be returned or paid for by the government.
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| File | Type | Posted |
|---|---|---|
| IHS IEE Representation Form.pdf |
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Item FreeStyle Libre 2 Sensor FreeStyle Libre 2 Reader FreeStyle Libre 2 TAA Reader Basic Info Product Description FreeStyle Libre 2 Sensor FreeStyle Libre 2 Reader FreeStyle Libre 2 TAA Reader Product Name FreeStyle Libre 2 Sensor FreeStyle Libre 2 Reader FreeStyle Libre 2 TAA Reader Manufacturer SKU 71992-01 71953-01 71951-01 Product Category Class II Class II Class II Product Subcategory N/A N/A N/A Brand Code Not provided Not provided Not provided Item Package Count 1 1 1 Item Weight 5 grams 65 grams 65 grams Country of Origin Ireland China Mexico FDA Submission Company Name Abbott Diabetes Care, Inc. Abbott Diabetes Care, Inc. Abbott Diabetes Care, Inc.
FDA Application Number K183591 K183591 K183591 Exempt from Drug Supply Chain Security Act (DSCSA)? Yes Yes Yes FDA Clearance date 15-Jun-20 15-Jun-20 15-Jun-20 Case Dimensions Component specification PRTs PRT26338 PRT25921 Does your case have inner packs? If Yes, how many? If No, leave blank NA NA NA If your case has inner packs, enter the number of items in one inner pack. If this product does not have inner packs leave this section blank. NA NA NA Number of Eaches in a Case 24 4 4 Shipping weight of case (lb) 5.97 3.84 3.84 Shipping weight of case (lb) 14.75 13.875 13.875 Case Width (in inches) 10.375 4.875 4.875 Case Height (in inches) 7.563 4.625 4.625 Cases per layer (TI) 12 24 24 Layers per pallet (HI) 7 9 9 Pallet Quantity 1080 216 216 Case cube ignore ignore ignore Item Length 4.688 4.258 4.25 Item Width 2.25 4.649 4.65 Item Height 3.5 3.349 3.35 Shipping weight of item (lb) 0.214 0.865 0.87 Inner Length NA NA NA Inner Width NA NA NA Inner Height NA NA NA Inner Weight NA NA NA Storage & Distribution Shelf Life of the product 9 months 3 years 3 years Storage temperatures (excursions allowed) 36 °F to 82 °F -4 °F to 140 °F -4 °F to 140 °F Contact name for temperature excursions Antonio Garcia, 408-348-4648 Antonio Garcia, 408-348-4648 Antonio Garcia, 408-348-4648 Store product upright? N/A N/A N/A Store product away from light? N/A N/A N/A Unit load dimensions (H x W x L) Stack height DO NOT STACK DO NOT STACK DO NOT STACK Unit load weight NA NA NA Layers per Unit Load NA NA NA Cases per unit load NA NA NA Full truck unit load NA NA NA Full truck cases NA NA NA Standard Ship Case 24 4 4 Date coded If yes, open or closed? NA NA NA Dating format NA NA NA Is this product restricted for air shipment (passenger, cargo, passenger/cargo) NA NA NA Ordering Information Minimum order quantity 24 4 4 Minimum Order from Plant 24 4 4 Minimum Order from Other N/A N/A N/A PO Identifier CS NDC CS NDC CS NDC Stat rate ? ? ?
Case COF Not provided Not provided Not provided Each Item Cost (numerical value only - do not include '$', enter the cost of a single Each) 54.43 70 70 Case Cost 1306.32 280 280
Unit MSRP Not provided Not provided Not provided HCPCS Code N/A N/A N/A Item External ID Type
Item UPC 357599800000 357599803001 357599805005 Item NDC 57599-0800-00 57599-0803-00 57599-0805-00 Item GTIN 00357599800000 00357599803001 00357599805005
Case External ID Type Case UPC NA NA NA Case NDC NA NA NA Case GTIN 30357599800001 30357599803002 30357599805006
Recommended sell unit to customer 24 4 4 Rx billing unit to pharmacy 1 1 1 10 digit NDC for ABC only (Amerisource Bergen) 57599-800-00 57599-803-00 57599-805-00 Safety & Regulations Contains hazardous material or is aerosol? No Yes Yes Hazardous Material Type N/A Lithium ion battery Lithium ion battery WERCs ID 1539399 1539394 1539397 Is the product a lithium battery, packed with a lithium battery or does it contain a lithium battery? No Yes Yes Contains Mercury (y/n) N N N TAA Compliant? Yes/No Y N Y Is product regulated by state or local restrictions? No No No Is the product a hazardous material according the Department of Transportation, Hazardous Materials Regulations, 49 CFR, Parts 171-178? No Yes Yes Hazmat United Nations Regulatory ID UN3481 UN3481 FDA Orange Book Code - - - Legend device? Yes Yes Yes State controlled? No No No ARCOS reportable? No No No Co-licensed? No No No Controlled substance? No No No Hazardous material/cytotoxic agent? No No No CA prop 65 carcinogen or reproductive toxic? No No No Have special clean up instruction? No No No Contain DEHP? No No No Is product regulated for shipment by DOT? Yes Yes Yes Class of trade - No restrictions Yes Yes Yes
Restricted Pharmacies No No No Restricted Hospitals/clinics/physician offices No No No Restricted from US territories? No No No Please check as appropriate - - -
Organic Inorganic X X X Antineoplastic Steroid/androgen Corrosive Oxidizer
Is this a marine pollutant? No No No DOT Hazard Class n/a 9 9 UN/ID for Sensors (same as reader?) n/a UN3481 UN3481 Packing Group n/a n/a n/a
Is this a reportable quantity? No No No RQ Threshold n/a n/a n/a Serialized? How? 2D, Linear, RFID 2D 2D 2D
REMS on this product? N/A N/A N/A If yes, is it managed by pharmacy? N/A N/A N/A Listed Chemical (Storage info) N/A N/A N/A DOES ITEM REQUIRE PUERTO RICO DEPT. OF HEALTH REGISTRATION? waiting on this waiting on this waiting on this
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