CRYOcheck™ Factor XI Deficient Plasma

GUDID 00843876000350

Precision Biologic Inc

Multiple coagulation factor IVD, reagent

• Primary Device ID: 00843876000350
• NIH Device Record Key: 2ad83166-4d8d-42ed-b292-ef83692bd299
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRYOcheck™ Factor XI Deficient Plasma
• Version Model Number: FDP11-15
• Company DUNS: 244713368
• Company Name: Precision Biologic Inc
• Device Count: 25
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843876000350 [Primary]
GS1	00843876010359 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981173

FDA Product Code

• GJT: Plasma, Coagulation Factor Deficient

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [CRYOcheck™ Factor XI Deficient Plasma]

• 00843876000350: FDP11-15
• 00843876000343: FDP11-10