AccessGUDID - DEVICE: SC90 50 BG, LYT, MET, OXI + QC (05700699460509)

GUDID

Device Identifier (DI) Information

Brand Name: SC90 50 BG, LYT, MET, OXI + QC
Version or Model: 946-050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 946-050
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699460509
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: SC90 50 BG, LYT, MET, OXI + QC

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):	Yes
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?
52858	Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies	A collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample, using multiple technologies such as ion-selective electrode (ISE) and haemoximetry in a single analyser. 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
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
KHP	ACID, LACTIC, ENZYMATIC METHOD
CGA	GLUCOSE OXIDASE, GLUCOSE
JJY	Multi-analyte controls, all kinds (assayed)
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
JGS	ELECTRODE, ION SPECIFIC, SODIUM
GHS	ASSAY, CARBOXYHEMOGLOBIN
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
KQI	ASSAY, FETAL HEMOGLOBIN
CHL	Electrode measurement, blood-gases (pco2, po2) and blood ph
JIX	Calibrator, multi-analyte mixture
JFP	Electrode, ion specific, calcium
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b7232612-1479-40ab-a7d5-62b4fda012de
Public Version Date: July 09, 2024
Public Version Number: 1
DI Record Publish Date: July 01, 2024