Universal IVF Medium

GUDID 20888937817199

Universal IVF Medium with phenol red. 10x10 ml

Origio A/S

IVF medium

• Primary Device ID: 20888937817199
• NIH Device Record Key: 1814a8dc-d52c-49a1-b2eb-bc7351ab0fd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal IVF Medium
• Version Model Number: 10311010D
• Company DUNS: 305424269
• Company Name: Origio A/S
• Device Count: 10
• 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: 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 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	00888937817195 [Unit of Use]
GS1	20888937817199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991279

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: 2016-07-15

On-Brand Devices [Universal IVF Medium ]

• 20888937817199: Universal IVF Medium with phenol red. 10x10 ml
• 20888937817151: Universal IVF Medium. 10x10 ml
• 20888937800306: Universal IVF Medium with phenol red. 60 ml
• 20888937800214: Universal IVF Medium. 60 ml