AccessGUDID - DEVICE: RAPIDPoint® 405/500 Measurement Cartridge (00630414477848)

GUDID

Device Identifier (DI) Information

Brand Name: RAPIDPoint® 405/500 Measurement Cartridge
Version or Model: 10310469
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 130522
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414477848
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: RAPIDPoint® 405/500 Measurement Cartridge (750 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.

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?
54498	Multiple blood gas analyte 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 blood gas analytes in a clinical specimen, using an ion-selective electrode (ISE) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020616	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
Handling Environment Temperature: between 2 and 25 Degrees Celsius
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: 9edffdb8-2709-41e5-b64a-aa8ba75b6518
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016