CardioChek 5700413

GUDID 10304040037758

CardioChek Capillary Tubes

HENRY SCHEIN, INC.

Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive 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