AccessGUDID - DEVICE: TacMed™ Vascular Access Kit (00199284492608)

GUDID

Device Identifier (DI) Information

Brand Name: TacMed™ Vascular Access Kit
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VAK
Company Name: TACTICAL MEDICAL SOLUTIONS, LLC

Primary DI Number: 00199284492608
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131480662 *Terms of Use

Device Description: The TacMed™ Vascular Access Kit provides all of the items necessary to gain vascular access and administer IV fluids, except for the fluids.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
66336	Non-dedicated vascular surgical procedure kit	A collection of various surgical instruments and supportive devices/materials intended to support multiple types of vascular surgical/access procedures (non-dedicated); it is not intended to support a catheterization procedure. It typically includes devices such as syringes, needles, scalpel, swabs, dressings, and drapes; it does not include any pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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: b98200bf-1fa8-423a-94b9-4631e2fa6270
Public Version Date: May 07, 2025
Public Version Number: 1
DI Record Publish Date: April 29, 2025