AccessGUDID - DEVICE: Blood Ketone Test Strips (16971404131199)

GUDID

Device Identifier (DI) Information

Brand Name: Blood Ketone Test Strips
Version or Model: SM311
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: e-Linkcare Meditech Co., Ltd

Primary DI Number: 16971404131199
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 15
Labeler D-U-N-S® Number*: 540481217 *Terms of Use

Device Description: Blood ketone Monitoring Meter with Blood Ketone Test Strips are intended for use for the quantitative measurement of B -hydroxybutyrate (B -ketone) in fresh capillary whole blood or venous 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):	No
Over the Counter (OTC):	Yes
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?
52853	Glucose/ketone/lipid profile 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 to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile.	Obsolete	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c75f1d8b-cb44-485e-a1fc-7c2e95feac66
Public Version Date: December 31, 2021
Public Version Number: 2
DI Record Publish Date: December 17, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
26971404131196	15	16971404131199		In Commercial Distribution	Box
26971404130939	30	16971404131199		In Commercial Distribution	Box
36971404131193	100	26971404131196	2021-12-30	Not in Commercial Distribution	carton
36971404130936	160	26971404130939	2021-12-30	Not in Commercial Distribution	Carton
36971404130004	100	26971404130939		In Commercial Distribution	carton
36971404130011	160	26971404131196		In Commercial Distribution	carton