AccessGUDID - DEVICE: Dimension® Flex Reagent Cartridge HB1C (00842768032615)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® Flex Reagent Cartridge HB1C
Version or Model: 10483822
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DF105A
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768032615
Issuing Agency: GS1
Commercial Distribution End Date: August 29, 2022
Device Count: 6
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Hemoglobin B1c Flex® reagent cartridges, HB1C Calibrator

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
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
LCP	ASSAY, GLYCOSYLATED HEMOGLOBIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102510	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: fbdf08fc-69a4-436f-8e38-bac18ce5124b
Public Version Date: August 30, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2016