AccessGUDID - DEVICE: V-LINK/VITALSHIELD (00085412088303)

GUDID

Device Identifier (DI) Information

Brand Name: V-LINK/VITALSHIELD
Version or Model: 6N8399
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6N8399
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412088303
Issuing Agency: GS1
Commercial Distribution End Date: October 12, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: V-LINK, Luer Activated Device with VITALSHIELD Protective Coating

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16858	Catheter injection port	A device intended to be placed on the Luer end of a catheter or intravenous (IV) tubing as a site of injection of substances into the in situ catheter/tubing. Some types may be designed as a Y-connector with an additional inlet (e.g., with a female Luer connection point) to facilitate sequential injection and infusion of fluids (e.g., medication followed by saline). It may be additionally intended for use as a heparin/saline lock by keeping the flush solution in the catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, administration, intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 792c1143-e24f-4f6c-a809-535d6830e78a
Public Version Date: August 18, 2025
Public Version Number: 5
DI Record Publish Date: September 24, 2016