AccessGUDID - DEVICE: BioHermes Glycohemoglobin Calibrator (06935784430511)

GUDID

Device Identifier (DI) Information

Brand Name: BioHermes Glycohemoglobin Calibrator
Version or Model: BH-CA01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HP-CA121
Company Name: Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

Primary DI Number: 06935784430511
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 528192913 *Terms of Use

Device Description: The Glycohemoglobin Calibrator is intended to be used as the calibration for glycohemoglobin analysis systems (the BH60 Automated Glycohemoglobin Analyzer and glycohemoglobin reagent kit) with the methodology of ion-exchange high-performance liquid chromatography (HPLC), manufactured by Wuxi BioHermes Bio & Medical Technology Co., Ltd.. Contents: 1x Level 1 (1mL), 1 x Level 2 (1mL).

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):	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?
53315	Glycated haemoglobin (HbA1c) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative measurement of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No Device Sizes

Device Record Status

Public Device Record Key: baa144ac-b6aa-4d03-bd58-97f142fe5b37
Public Version Date: January 13, 2022
Public Version Number: 1
DI Record Publish Date: January 05, 2022