AccessGUDID - DEVICE: Dimension® Flex® reagent cartridge PTN (00842768005619)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® Flex® reagent cartridge PTN
Version or Model: 10444940
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DF64
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768005619
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Phenytoin Flex® reagent cartridge, 112 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?
61897	Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug phenytoin (e.g., Dilantin) in a clinical specimen, using a nephelometry/turbidimetry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DIP	ENZYME IMMUNOASSAY, DIPHENYLHYDANTOIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K911056	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: fe42aa29-0476-42f8-b77e-db2129f01767
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016