AccessGUDID - DEVICE: TEG5000 HEMOSTASIS ANALYZER (30812747018412)

GUDID

Device Identifier (DI) Information

Brand Name: TEG5000 HEMOSTASIS ANALYZER
Version or Model: 07-066
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HAEMONETICS CORPORATION

Primary DI Number: 30812747018412
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 057827420 *Terms of Use

Device Description: TEG ANALYZER 5000, 230V, 60HZ, FG

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

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

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4eaa2b3a-4ff0-47c7-bffe-5a12de6d43ad
Public Version Date: October 02, 2023
Public Version Number: 4
DI Record Publish Date: 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
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

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

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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