AccessGUDID - DEVICE: Bartels (05391516747394)

GUDID

Device Identifier (DI) Information

Brand Name: Bartels
Version or Model: B1029-90D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B1029-90D
Company Name: CLARK LABORATORIES, INC.

Primary DI Number: 05391516747394
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 623214079 *Terms of Use

Device Description: FlexTrans Viral & Chlamydial Transport Medium

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:	No
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?
58697	Viral transport medium IVD	A vessel containing transport medium intended to be used for the preservation and transport of viral culture isolates from a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JSM	Culture Media, Non-Propagating Transport

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 50 x 2mL specimen vials

Device Record Status

Public Device Record Key: 331a0fd9-a46c-49d7-a228-87277dd68d18
Public Version Date: December 21, 2020
Public Version Number: 5
DI Record Publish Date: May 07, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-800-325-3424
Email: Customerservice@trinityusa.com

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