AccessGUDID - DEVICE: VersaTREK™ (00848838091742)

GUDID

Device Identifier (DI) Information

Brand Name: VersaTREK™
Version or Model: VersaTREK™ Myco Streptomycin, 7120-30
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REMEL, INC.

Primary DI Number: 00848838091742
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065769564 *Terms of Use

Device Description: No description.

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:	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?
30658	Multiple antimycobacterial minimum inhibitory concentration (MIC) IVD, kit	A collection of reagents or test strips and other associated materials, containing multiple antimicrobial agents at specified concentration gradients, intended to be used to determine the degree of susceptibility or the minimum inhibitory concentration (MIC) of a range of antimicrobials against a specific Mycobacterium organism, isolated from a clinical specimen by culture.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDB	System, Blood Culturing

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: 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: 572f2fd4-83de-4d5d-851d-632585e28bb5
Public Version Date: January 24, 2025
Public Version Number: 1
DI Record Publish Date: January 16, 2025