AccessGUDID - DEVICE: Dimension® Flex® reagent cartridge TRNF (00842768005244)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® Flex® reagent cartridge TRNF
Version or Model: 10444985
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DF103
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768005244
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Transferrin Flex® reagent cartridge, 120 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?
59041	Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of transferrin or a transferrin isoform(s) [e.g., beta-2-transferrin, carbohydrate deficient transferrin] in a clinical specimen, using a nephelometry/turbidimetry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DDG	TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K994294	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: 1c028489-7b12-4839-aa3d-a90bd1e0460a
Public Version Date: September 13, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016