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CONTROL, BLOOD CHEMISTR

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SPE2DS-27-T-1193Federal

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Solicitation SPE2DS-27-T-1193 is a request for quotations issued by the DLA Troop Support Medical Supply Chain for the procurement of two boxes of i-STAT PT Plus Control Reagent Level 1. This blood chemistry control is used for coagulation testing on the i-STAT 1 Government Field Kit analyzer. Each box contains ten 1.0 mL units. The items are regulated by the FDA under Regulation 864.7750 Class II and must be delivered FOB Destination to the USNS Comfort within 20 days after the order. The contract mandates strict quality and storage requirements, including refrigeration between 2 to 8 degrees Celsius and a non-extendable shelf life of 12 months. To ensure product viability, no more than one month may have elapsed from the date of manufacture to the date of delivery. Packaging must adhere to MIL-STD-2073-1E and Medical Marking Standard No. 1, with labels specifying the manufacture date, expiration date, and contract or lot number. Invoicing and receiving reports must be processed electronically through the Wide Area WorkFlow system.

General Info

Procurement of two i-STAT PT Plus Control Reagent boxes for USNS Comfort.

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

USNS COMFORT T AH 20, FPO, AE, 09566-4008, USA

Set-Aside

NONE

Documents

1
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Timeline

PhaseSolicitation
Posted

Solicitation

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Organization & Contact Information

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AgencyDepartment Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSF
Contacts1 person available
OfficeUSA
Office AddressUSA
Contacts

Full Description

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CONTROL,BLOOD CHEMISTRY
CONTROL,BLOOD CHEMISTRY
FEATURES I-STAT PT PLUS CONTROL REAGENT LEVEL 1;
FOR CONTROL OF COAGULATION TESTING. FOR USE WITH I-STAT PT PLUS
CARTRIDGE, TESTING PERFORMED ON ANALYZER,BLOOD GAS, I-STAT 1 GOVERNMENT
FIELD KIT.
UNIT OF ISSUE: BX (10 X 1.0 ML EACH PER BOX)
..
RA001: THIS DOCUMENT INCORPORATES TECHNICAL AND/OR QUALITY REQUIREMENTS
(IDENTIFIED BY AN 'R' OR AN 'I' NUMBER) SET FORTH IN FULL TEXT IN THE
DLA MASTER LIST OF TECHNICAL AND QUALITY REQUIREMENTS FOUND ON THE WEB
AT:
http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx
FOR SIMPLIFIED ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE SOLICITATION ISSUE DATE OR THE AWARD DATE CONTROLS. FOR LARGE ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE RFP ISSUE DATE APPLIES UNLESS A SOLICITATION AMENDMENT INCORPORATES A FOLLOW-ON REVISION, IN WHICH CASE THE AMENDMENT DATE CONTROLS.
..
RD003, COVERED DEFENSE INFORMATION POTENTIALLY APPLIES
..
RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT
..
RQ011: REMOVAL OF GOVERNMENT IDENTIFICATION FROM NON-ACCEPTED SUPPLIES
..
APPLICABLE TO ALL MEDICAL ACQUISITIONS:
PACKAGING AND PACKING SHALL BE COMMERCIAL AS
SPECIFIED IN THE PROCUREMENT DOCUMENT.
EACH COMPLETE UNIT SHALL BE PROPERLY PACKAGED
IN A SUITABLE SEALED UNIT CONTAINER CAPABLE
OF PROTECTING THE CONTENTS FROM DAMAGE AND/OR
BREAKAGE.
UNITS SHALL BE PACKED IN SUITABLE COMMERCIAL
EXTERIOR (SHIPPING) CONTAINERS (EXPORT WHEN
NECESSARY) WHICH SHALL INSURE ACCEPTANCE AND
SAFE DELIVERY BY COMMON OR OTHER CARRIER, AT
THE LOWEST RATE, TO POINT OF DELIVERY CALLED
FOR IN THE CONTRACT OR ORDER.
MATERIAL MUST BE MARKED IAW MEDICAL MARKING
STANDARD NO. 1. THIS SUPERCEDES ALL REFERENCES
TO MIL-STD-129.
COPIES OF MEDICAL MARKING STANDARD NO. 1
(MMS NO. 1) MAY BE OBTAINED BY CONTACTING DLA
TROOP SUPPORT VIA EMAIL TO contact@example.gov. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
..
SPE2DS-27-T-1193
SECTION B
RS011: Shelf-life requirement RS001 for a TYPE I (CODE H) item with a shelf life of 12 months (non-extendable) applies to this item.
SHALL HAVE A SHELF LIFE OF 12 MONTHS.
NOT MORE THAN 1 MONTHS SHALL HAVE ELAPSED FROM
DATE OF MANUFACTURE TO DATE OF DELIVERY TO THE
GOVERNMENT.
.
SHELF LIFE MARKINGS SHALL BE IN ACCORDANCE WITH
THE LATEST REVISION OF MMS1C.
. ALL LABELS SHALL INCLUDE:
DATE OF MANUFACTURE, EXPIRATION, OR RETEST DATE
CONTRACT NUMBER/LOT NUMBER.
..
REQUIRES REFRIGERATION STORAGE BETWEEN 2 TO 8 DEGREES CELSIUS
(36 TO 46 DEGREES FAHRENHEIT) DO NOT FREEZE
..
BIDDER: PLEASE SPECIFY SOURCE AND PART
NUMBER BEING SUPPLIED.
ADEQUATE DATA FOR THE NSN/Part Number: 6550-01-728-5703 Quantity: 2 BX Purchase Request: 7018938258QTY: 2 Delivery: 20 days ADO

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