AccessGUDID - DEVICE: Sensor Module, Li+ (00630414484563)

GUDID

Device Identifier (DI) Information

Brand Name: Sensor Module, Li+
Version or Model: 10318482
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3191840
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414484563
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Li+ Sensor module, an in vitro diagnostics device to be used on the RAPIDChem® 754 analyzer

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?
56683	Ion-selective analyser IVD, semi-automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of electrolytes and/or other ions in a clinical specimen using ion-specific membranes to selectively measure electrical potential against a reference electrode to determine the target ion concentration. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K000926	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ff54d7b5-4e2c-4e31-bb32-09a44057ab5a
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016