AccessGUDID - DEVICE: Nitro-tab Ketone Tablets (00657498002131)

GUDID

Device Identifier (DI) Information

Brand Name: Nitro-tab Ketone Tablets
Version or Model: 4000-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4000-100
Company Name: STANBIO LABORATORY, L.P.

Primary DI Number: 00657498002131
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 045361136 *Terms of Use

Device Description: Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood.

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:	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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 869b95de-760c-4a27-bc4a-3c8e49af2e8c
Public Version Date: March 19, 2019
Public Version Number: 1
DI Record Publish Date: March 11, 2019