IVM System

GUDID 60888937028203

MediCult IVM System. 4x10 ml

Coopersurgical, Inc.

IVF medium kit

• Primary Device ID: 60888937028203
• NIH Device Record Key: 380a1fec-62af-4668-8e77-c19643870869
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IVM System
• Version Model Number: 82214010M
• 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: 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	60888937028203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041284

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: 2026-02-13
• Device Publish Date: 2026-02-05

Devices Manufactured by Coopersurgical, Inc.

• 00888937028331 - ORIGIO Sequential Blast: 2026-02-13 ORIGIO Sequential Blast. 10 ml
• 00888937028348 - ORIGIO Sequential Blast: 2026-02-13 ORIGIO Sequential Blast 60 ml
• 00888937028355 - ORIGIO Sequential Blast: 2026-02-13 ORIGIO Sequential Blast with phenol red. 10 ml
• 00888937028386 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav. 10 ml
• 00888937028393 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav. 60 ml
• 00888937028409 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav with phenol red. 10 ml
• 00888937028416 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav with phenol red. 60 ml
• 00888937028430 - ORIGIO Sequential Fert: 2026-02-13 ORIGIO Sequential Fert