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ADMINISTRATION SET, INT

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SPE2DS-27-T-1953Federal

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Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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Solicitation SPE2DS-27-T-1953, issued by the Defense Logistics Agency (DLA) for the Medical Supply Chain, is for the procurement of three packages of intravenous fluid administration sets. Each set is specified as an IV administration set with 60 drops/ml and a 150 ml burette, identified by NSN 6515-01-538-5709. The unit of issue is a package consisting of 20 individual units. Delivery is required within 20 days after order, with FOB Destination and destination inspection and acceptance. The items are FDA-regulated Class II devices requiring a 510(k) and must adhere to strict shelf-life requirements of 48 months, with no more than 7 months elapsed from manufacture to delivery. Packaging must be commercial and sealed to prevent damage, with marking following Medical Marking Standard No. 1 (MMS No. 1) and MIL-STD-2073-1E. The contract incorporates various FAR and DFARS clauses, including requirements for the Buy American program, NIST SP 800-171 assessment, and safeguarding covered defense information. Payment is processed electronically via the Wide Area WorkFlow (WAWF) system.

General Info

DLA solicitation for three packages of FDA-regulated IV fluid administration sets.

Agency

Department Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSF

NAICS

339112 - Surgical and Medical Instrument Manufacturing

Place of Performance

2434 20TH STREET, FORT CAMPBELL, KY, 42223-5349, USA

Set-Aside

NONE

Documents

1
PDF, High priority: read this first19 pages · rfq
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Timeline

PhaseSolicitation
Posted

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Organization & Contact Information

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AgencyDepartment Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSF
Contacts1 person available
OfficeUSA
Organization / AgencyDepartment Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSF
Office AddressUSA
Contacts
DOROTHY MARQUIS
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Full Description

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ADMINISTRATION SET,INTRAVENOUS FLUIDS
ADMINISTRATION SET,IV,60 DROPS/ML,150 ML BURETTE.
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 Sign up to see this detail. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
UNIT OF ISSUE: PACKAGE (PG) 1 PG = 20 EA
SHALL HAVE A SHELF LIFE OF 48 MONTHS. NOT MORE THAN 7 MONTHS SHALL HAVE ELAPSED FROM DATE OF MANUFACTURER TO DATE OF DELIVERY TO THE GOVERNMENT.
SHELF LIFE MARKINGS SHALL BE IN ACCORDANCE WITH THE LATEST REVISION OF MMS1A. .ALL LABELS SHALL INCLUDE:
DATE OF MANUFACTURER, EXPIRATION, OR RETEST DATE CONTRACT NUMBER/LOT NUMBER.
RS021: Shelf-life requirement RS001 for a TYPE I (CODE R) item with a shelf life of 48 months (non-extendable) applies to this item.
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.
RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT
SPE2DS-27-T-1953
SECTION B
RQ011: REMOVAL OF GOVERNMENT IDENTIFICATION FROM NON-ACCEPTED SUPPLIES
This device or drug is regulated by the FDA. Note to Buyers: The contracting official shall send a referral in EBS to the product specialist for confirmation. Please include bidder name and bidder contact information, manufacturer name, manufacturer part number, and item description.
REGULATION 880.5440 CLASS II EVEN THOUGH A 510(K) IS REQUIRED, IT IS NECESSARY TO MEET OTHER REQUIREMENTS FOR MARKETING. THESE INCLUDE: REGISTRATION AND LISTING, LABELING OR GMP'S.
RD003, COVERED DEFENSE INFORMATION POTENTIALLY APPLIES
.
SHALL BE MARKED IAW THE LATEST EDITION OF
THE MEDICAL MARKING STANDARD NO. 1.
MMS NO. 1 IS AVAILABLE ONLINE AT:
https://www.dla.mil/Logistics-Operations/Packaging/
B. BRAUN MEDICAL INC 11171 P/N 375113
DLA issues this document using the DoD authorized unit of issue, please refer to the following URL to determine the corresponding ANSI X12 unit of issue.
https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.dla.mil%2FPortals%2F104%2FDocuments% 2FDLMS%2FeApplications%2FLogDataAdmin%2FUnitofIssueandPurchaseUnit.xlsx&wdOrigin=BROWSELINK
CLIN PR PRLI UI QUANTITY UNIT PRICE TOTAL PRICE.
0001 7019120288 0001 PG 3.000
NSN/MATERIAL:6515015385709
DELIVERY (IN DAYS):0020
DELIVER FOB: DESTINATION
QTY VARIANCE: PLUS 0% MINUS 0%
INSPECTION POINT: DESTINATION
ACCEPTANCE POINT: DESTINATION
PREP FOR DELIVERY:
PKGING DATA MIL-STD-2073-1E
SPECIAL NSN/Part Number: 6515-01-538-5709 Quantity: 3 PG Purchase Request: 7019120288QTY: 3 Delivery: 20 days ADO

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