Gamete Buffer

GUDID 06976438300088

Gamete Buffer, 125mL

Gimbo Medical Technology Shenzhen Co., Ltd.

IVF medium

• Primary Device ID: 06976438300088
• NIH Device Record Key: 838fb0e4-184d-4b88-b458-cb3857a94eb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gamete Buffer
• Version Model Number: GB125
• Company DUNS: 722458269
• Company Name: Gimbo Medical Technology Shenzhen Co., Ltd.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976438300088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234023

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: 2024-07-03
• Device Publish Date: 2024-06-25

On-Brand Devices [Gamete Buffer]

• 06976438300101: Gamete Buffer, 500mL
• 06976438300095: Gamete Buffer, 250mL
• 06976438300088: Gamete Buffer, 125mL
• 06976438300071: Gamete Buffer, 60mL