AccessGUDID - DEVICE: IDG/Sanzay (00850053916113)

GUDID

Device Identifier (DI) Information

Brand Name: IDG/Sanzay
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C243
Company Name: IDG/SANZAY Corporation

Primary DI Number: 00850053916113
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 948875013 *Terms of Use

Device Description: For the In Vitro quantitative determination of glucose in human serum or plasma.

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:	No
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?
52854	Glucose/haemoglobin (Hb) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glucose and haemoglobin (Hb) in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CFR	Hexokinase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K000102	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 250 Milliliter
Total Volume: 1 Liter
Total Volume: 240 Milliliter

Device Record Status

Public Device Record Key: 7e858fc2-93a9-4dc3-aade-904dacae8b73
Public Version Date: July 03, 2024
Public Version Number: 1
DI Record Publish Date: June 25, 2024