Embryo Thawing Pack

GUDID 60888937028180

Embryo Thawing Pack. 4x10 ml

Coopersurgical, Inc.

IVF medium kit

• Primary Device ID: 60888937028180
• NIH Device Record Key: 802d4ba9-cd03-4335-b41e-b65e45815600
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embryo Thawing Pack
• Version Model Number: 10984010M
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	60888937028180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991335

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: 2026-02-12
• Device Publish Date: 2026-02-04

Devices Manufactured by Coopersurgical, Inc.

• 00888937028126 - Biopsy Medium: 2026-02-12 Biopsy Medium. 10 ml
• 00888937028157 - Sperm Freezing Medium: 2026-02-12 Sperm Freezing Medium. 10ml
• 00888937028218 - PVP Medium: 2026-02-12 PVP Medium with phenol red. 1 ml
• 60888937028272 - Universal IVF Medium: 2026-02-12 Universal IVF Medium. 60 ml
• 00888937028287 - Universal IVF Medium: 2026-02-12 Universal IVF Medium with phenol red. 60 ml
• 00888937028317 - UTM: 2026-02-12 UTM Transfer Medium with phenol red. 10 ml
• 00888937028324 - UTM: 2026-02-12 UTM Transfer Medium
• 00888937028577 - Flushing Medium: 2026-02-12 Flushing Medium without Heparin. 125 ml