AccessGUDID - DEVICE: RAPIDLab® 348/348EX HCT Slope (00630414055930)

GUDID

Device Identifier (DI) Information

Brand Name: RAPIDLab® 348/348EX HCT Slope
Version or Model: 10309776
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 105670
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414055930
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: RAPIDLab® 348/348EX HCT Slope for in vitro diagnostics use with the RAPIDLab® 348/348EX 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?
52859	Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be 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
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K962021	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
Special Storage Condition, Specify: Keep away from sunlight
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a95e7b0e-7358-405a-a365-7c148154162b
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016