CardioChek 5700413

GUDID 10304040037758

CardioChek Capillary Tubes

HENRY SCHEIN, INC.

Capillary blood collection tube IVD, no additive

• Primary Device ID: 10304040037758
• NIH Device Record Key: de9f29ef-5a15-439f-b172-f7713a1b406e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioChek
• Version Model Number: 5700413
• Catalog Number: 5700413
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 16
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040037751 [Unit of Use]
GS1	10304040037758 [Primary]

FDA Product Code

• GIO: TUBE, COLLECTION, CAPILLARY BLOOD

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-19
• Device Publish Date: 2017-01-05

On-Brand Devices [CardioChek]

• 00304040040539: CardioChek Plus Analyzer Starter Pack
• 00304040037713: CardioChek Plus Analyzer
• 90304040038522: CardioChek Glucose Test
• 10304040037758: CardioChek Capillary Tubes
• 10304040037741: CardioChek Lipid Panel Test
• 20304040037731: CardioChek 15Lipid/15Glucose
• 10304040037727: Cardiochek eGLU Glucose Test