AccessGUDID - DEVICE: Dimension Vista® Flex® reagent cartridge FSH (00842768026430)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Vista® Flex® reagent cartridge FSH
Version or Model: 10488533
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K6460
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768026430
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: LOCI Follicle Stimulating Hormone Flex® reagent cartridge, 200 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?
54187	Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of follicle stimulating hormone (FSH) in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NGA	TEST, FOLLICLE STIMULATING HORMONE (FSH), OVER THE COUNTER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 3da9c9ca-419a-4fae-9c68-3ebeb09caf16
Public Version Date: November 18, 2021
Public Version Number: 2
DI Record Publish Date: September 24, 2020