AccessGUDID - DEVICE: Dimension Vista® Flex® reagent cartridge BHCG (00842768015540)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Vista® Flex® reagent cartridge BHCG
Version or Model: 10445107
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K6430
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768015540
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Beta Human Chorionic Gonadotropin Flex® reagent cartridge, 160 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?
54215	Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, in a clinical specimen using a chemiluminescent immunoassay method. It is used in foetal screening of Down syndrome and other chromosomal abnormalities during pregnancy.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DHA	SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063754	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: 5d63d3c4-1d11-43f4-9629-ddd5b8ea7637
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016