BlastThaw

GUDID 60888937816244

BlastThaw. 4x2 ml

Origio A/S

IVF medium kit

• Primary Device ID: 60888937816244
• NIH Device Record Key: c4ee062f-7a74-4db1-b34a-81dcc16c9709
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BlastThaw
• Version Model Number: 10544002D
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	60888937816244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031486

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

On-Brand Devices [BlastThaw]

• 60888937816244: BlastThaw. 4x2 ml
• 60888937800601: BlastThaw. 2x10 ml