TEG5000 HEMOSTASIS SYSTEM

GUDID 20812747018132

DISPOSABLE CUPS & PINS, CLEAR

HAEMONETICS CORPORATION

Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory

• Primary Device ID: 20812747018132
• NIH Device Record Key: cc61f820-422e-48df-822a-42fecd80c364
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEG5000 HEMOSTASIS SYSTEM
• Version Model Number: 6211
• Company DUNS: 057827420
• Company Name: HAEMONETICS CORPORATION
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	20812747018132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993678

FDA Product Code

• JPA: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

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: 2017-07-11

On-Brand Devices [TEG5000 HEMOSTASIS SYSTEM]

• 20812747018132: DISPOSABLE CUPS & PINS, CLEAR
• 20812747018125: PLATELETMAPPING MULTIPAK AA
• 20812747018118: PLATELETMAPPING MULTIPAK ADP
• 20812747018101: PLATELETMAPPING MULTIPAK ADP & AA
• 20812747018088: RAPIDTEG REAGENT
• 20812747018033: LEVEL II CONTROL
• 20812747018026: LEVEL I CONTROL
• 20812747018019: DISPOSABLE CUPS & PINS HEPARINASE
• 20812747018002: KAOLIN