TEG5000 HEMOSTASIS ANALYZER

GUDID 30812747018184

TEG ANALYZER, 5000, 120V, 60HZ, FG

HAEMONETICS CORPORATION

Coagulation analyser IVD, laboratory, semi-automated

• Primary Device ID: 30812747018184
• NIH Device Record Key: 73837786-3f91-4cc7-9ab2-23f00f21347e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEG5000 HEMOSTASIS ANALYZER
• Version Model Number: 07-022
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com
• Phone: +1(800)-537-2802
• Email: pirdesk@Haemonetics.com

Device Dimensions

• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz
• Pressure: 60 Hertz

Device Identifiers

Device Issuing Agency	Device ID
GS1	30812747018184 [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 ANALYZER]

• 30812747018412: TEG ANALYZER 5000, 230V, 60HZ, FG
• 30812747018184: TEG ANALYZER, 5000, 120V, 60HZ, FG