DEVICE: TEG5000 HEMOSTASIS ANALYZER (30812747018412)

Device Identifier (DI) Information

TEG5000 HEMOSTASIS ANALYZER
07-066
In Commercial Distribution

HAEMONETICS CORPORATION
30812747018412
GS1

1
057827420 *Terms of Use
TEG ANALYZER 5000, 230V, 60HZ, FG
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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GMDN

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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
JPA SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K993678 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4eaa2b3a-4ff0-47c7-bffe-5a12de6d43ad
October 02, 2023
4
July 11, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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No
No CLOSE

Customer Contact

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+1(800)-537-2802
pirdesk@Haemonetics.com
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