AccessGUDID - DEVICE: RAPIDPOINT® 350 Sampler Module (00630414566313)

GUDID

Device Identifier (DI) Information

Brand Name: RAPIDPOINT® 350 Sampler Module
Version or Model: 10375810
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10375810
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414566313
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: RAPIDPOINT® 350 Sampler 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?
56672	Blood gas/haemoximetry analyser IVD, point-of-care	A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen.	Active	false

FDA Product Code

[?]

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

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 88e263f4-beb1-4cac-bc46-186f1b242b62
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016