Bartels B1029-375

GUDID 05391516747295

Tissue Culture Refeeding Medium

CLARK LABORATORIES, INC.

Cell culture medium IVD

• Primary Device ID: 05391516747295
• NIH Device Record Key: b114fbc7-9c9b-4b0d-a951-d2a35a830122
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bartels
• Version Model Number: B1029-375
• Catalog Number: B1029-375
• Company DUNS: 623214079
• Company Name: CLARK LABORATORIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391516747295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K834113

FDA Product Code

• KIT: Media And Components, Synthetic Cell And Tissue Culture

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-06
• Device Publish Date: 2017-05-07

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• 05391516747356: Chlamydiae Isolation Medium with Cycloheximide
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• 05391516747301: Phosphate Buffered Saline with Mg++ and Ca++
• 05391516747295: Tissue Culture Refeeding Medium
• 05391516747288: Tissue Culture Refeeding Medium
• 05391516747271: Tissue Culture Refeeding Medium
• 05391516747264: ViraTrans™, Viral Transport Media
• 05391516747257: ViraTrans, Viral Transport Medium
• 05391516746670: Legionella Urinary Antigen Controls Only