IVM System

GUDID 60888937804128

MediCult IVM System. 4x10 ml

Origio A/S

IVF medium kit IVF medium kit

• Primary Device ID: 60888937804128
• NIH Device Record Key: 7204bfb9-168c-4e4c-95bf-e244eafa8680
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IVM System
• Version Model Number: 82214010D
• Company DUNS: 305424269
• Company Name: Origio A/S
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	60888937804128 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-28

Devices Manufactured by Origio A/S

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• 00888937833027 - SynVitro Hyadase: 2021-01-26 SynVitro Hyadase. 5x1 ml
• 00888937819342 - CSC Freezing Medium: 2019-09-12 CSC Freezing Medium - Choline Substituted Cryopreservation Freezing Medium. 10 ml
• 00888937801491 - EmbryoAssist: 2019-08-29 EmbryoAssist. 10 ml
• 00888937833058 - SAGE 1-Step: 2019-03-11 Sage 1-Step GM-CSF with HSA. 3 ml
• 00888937833072 - SAGE 1-Step: 2019-03-11 SAGE 1-Step GM-CSF with SPS. 3 ml.
• 20888937972348 - Transem Spherical: 2019-01-23 Embryo transfer catheter, spherical tip.
• 20888937972355 - EchoGen Spherical: 2019-01-23 Embryo transfer catheter, echogenic/spherical. 24 cm