AccessGUDID - DEVICE: FREND Free T4 (08809317540191)

GUDID

Device Identifier (DI) Information

Brand Name: FREND Free T4
Version or Model: FRT4-HB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FRT4 020
Company Name: NanoEnTek, Inc.

Primary DI Number: 08809317540191
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687910463 *Terms of Use

Device Description: It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System.

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):	Yes
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?
54414	Free thyroxine (FT4) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of free thyroxine (FT4) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEC	Radioimmunoassay, Free Thyroxine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152422	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: 44ede2dc-3bdc-418c-a306-5fff6586e4ed
Public Version Date: July 22, 2024
Public Version Number: 5
DI Record Publish Date: September 30, 2016