AccessGUDID - DEVICE: KETOCOACH 50 BLOOD KETONE TEST STRIPS (00860060002327)

GUDID

Device Identifier (DI) Information

Brand Name: KETOCOACH 50 BLOOD KETONE TEST STRIPS
Version or Model: S5640791
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMVENTUREX, INC.

Primary DI Number: 00860060002327
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117225590 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	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?
53341	Ketone (acetoacetate) 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 qualitative and/or quantitative detection of ketone (acetoacetate) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182593	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: 5fd3d4b7-3c10-4ed2-afe5-43c5b63d41f4
Public Version Date: January 07, 2020
Public Version Number: 1
DI Record Publish Date: December 30, 2019