AccessGUDID - DEVICE: Fibrotek (00859394006040)

GUDID

Device Identifier (DI) Information

Brand Name: Fibrotek
Version or Model: 70-410
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-410
Company Name: R 2 DIAGNOSTICS, INC.

Primary DI Number: 00859394006040
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 956610125 *Terms of Use

Device Description: Fibrinogen assay 100 DET

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
55997	Fibrinogen assay (factor I) IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the quantitative measurement of fibrinogen (factor I) in a clinical specimen, using a clotting method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQJ	System, Fibrinogen Determination
GIS	Test, Fibrinogen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042919	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: 66e55df2-d77d-4c53-934d-4f614535f860
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 15, 2016

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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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