AccessGUDID - DEVICE: Dimension® EXL™ VB12 Flex® reagent cartridge (00630414976624)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® EXL™ VB12 Flex® reagent cartridge
Version or Model: 10463371
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RF642
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414976624
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: LOCI Vitamin B12 Flex® reagent cartridge, 80 tests

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?
60779	Vitamin B12 IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of vitamin B12, also known as cobalamin, in a clinical specimen, using a chemiluminescent immunoassay.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CDD	RADIOASSAY, VITAMIN B12

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133512	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: 038c57d3-ed8c-4b2c-a761-33236e8d3e0d
Public Version Date: August 05, 2022
Public Version Number: 7
DI Record Publish Date: September 24, 2016