AccessGUDID - DEVICE: RAPIDChem® 700 Lithium Sensor (00630414451862)

GUDID

Device Identifier (DI) Information

Brand Name: RAPIDChem® 700 Lithium Sensor
Version or Model: 10308981
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 583772
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414451862
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: RAPIDChem® 700 Lithium Sensor for in vitro diagnostics use with the Rapidchem ® 700 systems

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?
30197	Lithium electrode IVD	An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of lithium ions in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
JIH	FLAME PHOTOMETRY, LITHIUM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002407	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 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cdf1e5f2-c0ce-4eea-9205-7dc96058b901
Public Version Date: November 19, 2021
Public Version Number: 6
DI Record Publish Date: September 24, 2016