AccessGUDID - DEVICE: RAPIDPoint® 400 Measurement Cartridge (00630414947525)

GUDID

Device Identifier (DI) Information

Brand Name: RAPIDPoint® 400 Measurement Cartridge
Version or Model: 10844810
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10844810
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414947525
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: RAPIDPoint® 400 Measurement Cartridge (100 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct is an invitro diagnostics device which is intended to be used on the RAPIDPoint® 400 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?
52861	Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0612b821-d14a-4943-8429-291f4530e7f1
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016