DEVICE: TEG5000 HEMOSTASIS ANALYZER (30812747018412)
Device Identifier (DI) Information
TEG5000 HEMOSTASIS ANALYZER
07-066
In Commercial Distribution
HAEMONETICS CORPORATION
07-066
In Commercial Distribution
HAEMONETICS CORPORATION
TEG ANALYZER 5000, 230V, 60HZ, FG
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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66878 | Blood viscoelasticity analyser IVD |
An electrically-powered laboratory instrument intended to be used for the determination of blood rheological properties (thromboelastography), namely blood viscosity and elasticity, in a whole blood specimen. Its principle of operation is based on detection of blood resistance changes upon vibrations of a resonating probe. The device is typically used in the evaluation of the functional state of haemostasis in patients with haemostatic disorders or haemorrhagic complications, or who are receiving antithrombotic or anticoagulant therapy.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K993678 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4eaa2b3a-4ff0-47c7-bffe-5a12de6d43ad
October 02, 2023
4
July 11, 2017
October 02, 2023
4
July 11, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)-537-2802
pirdesk@Haemonetics.com
pirdesk@Haemonetics.com