AccessGUDID - DEVICE: Dimension® LDI Flex® reagent cartridge (00842768027314)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® LDI Flex® reagent cartridge
Version or Model: 10284483
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DF54
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768027314
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Lactate Dehydrogenase Flex® reagent cartridge, 480 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?
53072	Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total lactate dehydrogenase (LDH) in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CFJ	NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE

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: cb4bd52e-1525-43b5-bff6-c584d0320c65
Public Version Date: July 06, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016