CRYOcheck™ Reference Control Normal

GUDID 00843876000053

Precision Biologic Inc

Multiple coagulation factor IVD, control

• Primary Device ID: 00843876000053
• NIH Device Record Key: 2021a85c-9b4d-46f6-a348-4d689b42daea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRYOcheck™ Reference Control Normal
• Version Model Number: RCN-05
• 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	00843876000053 [Primary]
GS1	00843876010052 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013708

FDA Product Code

• GIZ: Plasma, Control, Normal

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™ Reference Control Normal]

• 00843876000060: RCN-10
• 00843876000053: RCN-05