AccessGUDID - DEVICE: Dimension Vista System Flex reagent cartridge A1C KIT (00630414006666)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Vista System Flex reagent cartridge A1C KIT
Version or Model: 10720885
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K3105B
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414006666
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: A1C Reagent Kit

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?
59090	Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c) in a clinical specimen, using a nephelometry/turbidimetry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PDJ	Hemoglobin A1c test system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173909	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
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8e76ee1e-adab-40ff-ac82-3c6baf7f2a9c
Public Version Date: November 18, 2021
Public Version Number: 4
DI Record Publish Date: February 12, 2019