ORIGIO Gradient 100

GUDID 20888937816840

ORIGIO Gradient 100, 4x125 ml

Origio A/S

IVF medium IVF medium

• Primary Device ID: 20888937816840
• NIH Device Record Key: 04a57677-a17e-493c-8e34-ca77a5df4cc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORIGIO Gradient 100
• Version Model Number: 84004125D
• Company DUNS: 305424269
• Company Name: Origio A/S
• Device Count: 4
• 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

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937832242 [Unit of Use]
GS1	20888937816840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153267

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-18

On-Brand Devices [ORIGIO Gradient 100]

• 20888937816840: ORIGIO Gradient 100, 4x125 ml
• 00888937816822: ORIGIO Gradient 100, 60 ml