AccessGUDID - DEVICE: Calibration gas 1 (05700699621696)

GUDID

Device Identifier (DI) Information

Brand Name: Calibration gas 1
Version or Model: 962-169
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 962-169
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699621696
Issuing Agency: GS1
Commercial Distribution End Date: September 21, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: Calibration gas 1, 10bar on-board gas bottle

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?
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
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
KQI	ASSAY, FETAL HEMOGLOBIN
CIG	DIAZO COLORIMETRY, BILIRUBIN
JGS	ELECTRODE, ION SPECIFIC, SODIUM
KHP	ACID, LACTIC, ENZYMATIC METHOD
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE
CGA	GLUCOSE OXIDASE, GLUCOSE
GHS	ASSAY, CARBOXYHEMOGLOBIN

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
Special Storage Condition, Specify: May burst if heated. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Protect from sunlight. Do not pierce or burn, even after use.
Storage Environment Temperature: between -40 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ffbabc24-630f-4dca-98bb-c917dbc5d692
Public Version Date: September 28, 2023
Public Version Number: 4
DI Record Publish Date: September 01, 2016