AccessGUDID - DEVICE: RAPIDPOINT® 350 Sensor Module (00630414566337)

GUDID

Device Identifier (DI) Information

Brand Name: RAPIDPOINT® 350 Sensor Module
Version or Model: 10375812
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10375812
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414566337
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: RAPIDPOINT® 350 Sensor Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 350 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?
52866	Multiple electrolyte IVD, kit, ion-selective electrode (ISE)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen, using an ion-selective electrode (ISE) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JGS	ELECTRODE, ION SPECIFIC, SODIUM
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
GKF	INSTRUMENT, HEMATOCRIT, AUTOMATED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021515	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 5 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e1bdb2c0-aaee-4e15-ae0f-5d77e8f1fdd9
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016