AccessGUDID - DEVICE: Calibration Solution 2 (05700699441294)

GUDID

Device Identifier (DI) Information

Brand Name: Calibration Solution 2
Version or Model: 944-129
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 944-129
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699441294
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: S1830 Calibration Solution 2, 200 mL, for ABL800 FLEX

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?
35933	Multiple blood gas analyte IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.	Active	false

FDA Product Code

[?]

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

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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d0a7a478-9ebd-4468-9d3f-d9351db30ea2
Public Version Date: November 27, 2020
Public Version Number: 3
DI Record Publish Date: September 01, 2016