Bartels

Basic Information

• Brand Name: Bartels
• Primary DI: 05391516747394
• Version / Model: B1029-90D
• Catalog Number: B1029-90D
• Company Name: CLARK LABORATORIES, INC.
• Labeler DUNS: 623214079
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-07
• Public Version: 5
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 331a0fd9-a46c-49d7-a228-87277dd68d18

Device Description

FlexTrans Viral & Chlamydial Transport Medium

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSM	Culture Media, Non-Propagating Transport	Microbiology	866.2390	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516747394	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius