AccessGUDID - DEVICE: Calibration Solution (05700699440648)

GUDID

Device Identifier (DI) Information

Brand Name: Calibration Solution
Version or Model: 944-064
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 944-064
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699440648
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: S1720 Calibration Solution 1 200 mL, for ABL7XX.

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
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
JJS	CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
CGA	GLUCOSE OXIDASE, GLUCOSE
GKF	INSTRUMENT, HEMATOCRIT, AUTOMATED
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
JGS	ELECTRODE, ION SPECIFIC, SODIUM
KHP	ACID, LACTIC, ENZYMATIC METHOD
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
CIG	DIAZO COLORIMETRY, BILIRUBIN

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: e77d05f3-de08-4697-8cc9-822fd1d03e5d
Public Version Date: November 27, 2020
Public Version Number: 3
DI Record Publish Date: September 01, 2016