TEG5000

GUDID 10812747018159

PIPETTE KIT, 1000UL

HAEMONETICS CORPORATION

Coagulation analyser IVD, laboratory

• Primary Device ID: 10812747018159
• NIH Device Record Key: 24490bd4-a876-4f61-a12b-b28b50832e10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEG5000
• Version Model Number: 01-097
• 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: 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

Device Dimensions

• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10812747018159 [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: 4
• Public Version Date: 2022-09-16
• Device Publish Date: 2017-03-13

On-Brand Devices [TEG5000]

• 10812747018456: ELECTRONIC PIPPETTE KIT, 1000UL
• 10812747018159: PIPETTE KIT, 1000UL
• 10812747018142: PIPETTE KIT, 100UL