ViaBL™ Super-Fast Blastocyst Warming Kit

GUDID 20888937027994

ViaBL™ Super-Fast Blastocyst Warming Kit, ART-8035 (in plastic cryo vials): 6x2 ml of 1,0 M ART-8031-A Sucrose Warming Solution.

Coopersurgical, Inc.

IVF medium kit

• Primary Device ID: 20888937027994
• NIH Device Record Key: f1486d9e-ad92-4004-bf8b-87bfc4e95500
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViaBL™ Super-Fast Blastocyst Warming Kit
• Version Model Number: ART-8035
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: true
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20888937027994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170560

FDA Product Code

• MQL: Media, Reproductive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-28
• Device Publish Date: 2025-03-20

Devices Manufactured by Coopersurgical, Inc.

• 20888937027994 - ViaBL™ Super-Fast Blastocyst Warming Kit: 2025-03-28ViaBL™ Super-Fast Blastocyst Warming Kit, ART-8035 (in plastic cryo vials): 6x2 ml of 1,0 M ART-8031-A Sucrose Warming Solution.
• 20888937027994 - ViaBL™ Super-Fast Blastocyst Warming Kit: 2025-03-28 ViaBL™ Super-Fast Blastocyst Warming Kit, ART-8035 (in plastic cryo vials): 6x2 ml of 1,0 M ART-8031-A Sucrose Warming Solutio
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