AccessGUDID - DEVICE: Atellica CH A1c_3 Calibrator (00630414597300)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica CH A1c_3 Calibrator
Version or Model: 11099328
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11099328
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414597300
Issuing Agency: GS1
Commercial Distribution End Date: August 01, 2022
Device Count: 2
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Hemoglobin A1c (A1c_3) Calibrator Atellica CH - CAL 4 x 2 x 0.5mL

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):	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?
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
JIX	Calibrator, multi-analyte mixture

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081895	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
No Device Sizes

Device Record Status

Public Device Record Key: ca070708-a5f2-4f69-bf7f-4f1527931420
Public Version Date: August 01, 2022
Public Version Number: 7
DI Record Publish Date: December 22, 2017