LENS, SCLERAL, OCULAR LA
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Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
This is a disposable, molded plastic scleral lens and ocular lavage device designed for directed irrigation, featuring fins to evenly distribute the lavage solution and integrated silicone tubing with an adapter for connection to intravenous solutions. The item is classified as a Type I (Code S) medical product with a non-extendable shelf life of 60 months and is subject to FDA regulation as a Class I device, requiring compliance with registration, listing, labeling, and good manufacturing practices, though a 510(k) submission may or may not be required. All labeling and marking must adhere to Medical Marking Standard No. 1, superseding MIL-STD-129, and government identification must be removed from non-accepted supplies. The device is procured under the NSN 6540-01-296-2130 with a unit of issue of 1 PG equaling 12 units, and must be packaged in accordance with MIL-STD-2073-1E. The solicitation SPE2DS-26-T-295A outlines a firm-fixed price contract requiring delivery of one package within five days FOB destination, with no variance allowed in quantity. Inspection and acceptance occur at the destination, and the item is sourced from approved manufacturers including Armstrong Medical Industries, Inc and Mortan Inc. Technical and quality requirements are governed by the DLA Master List, and the contract includes provisions for covered defense information. The primary point of contact is Kendall Jones at DLA, and the procurement falls under NAICS code 336611 for surgical appliance and supplies manufacturing, with delivery targeted to Ellsworth AFB, SD.
General Info
Agency
NAICS
Place of Performance
2900 DOOLITTLE DR BLDG 6000, ELLSWORTH AFB, SD, 57706-4821, USSet-Aside
Documents
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Timeline
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Organization & Contact Information
Full Description
LENS, SCLERAL, OCULAR LAVAGE<(>,<)>
PLASTIC; MOLDED; DISPOSABLE; DIRECTIONAL
FINS TO PROVIDE FOR DISTRIBUTION OF THE
LAVAGE; WITH SILICONE TUBING AND ADAPTER
FOR CONNECTION TO INTRAVENOUS SOLUTION, 12S
.
1 PG = 12 EA
RS023: Shelf-life requirement RS001 for a TYPE I (CODE S) item with a shelf life of 60 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
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 (886.4360), CLASS I. EVEN THOUGH A 510(K) (IS/IS NOT) REQUIRED, IT IS NECESSARY TO MEET OTHER REQUIREMENTS FOR MARKETING. THESE INCLUDE: REGISTRATION AND LISTING, LABELING, OR GMP’S. . 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 fssb@dla.mil. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
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.
SPE2DS-26-T-295A
SECTION B
RD003, COVERED DEFENSE INFORMATION POTENTIALLY APPLIES
ARMSTRONG MEDICAL INDUSTRIES, INC 57794 P/N AE-1695
MORTAN INC. 0B000 P/N MT2000
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 7017684472 0001 PG 1.000
NSN/MATERIAL:6540012962130
DELIVERY (IN DAYS):0005
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: 6540-01-296-2130 Quantity: 1 PG Purchase Request: 7017684472QTY: 1 Delivery: 5 days ADO
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