AccessGUDID - DEVICE: Calibration Solution (05700699440211)

GUDID

Device Identifier (DI) Information

Brand Name: Calibration Solution
Version or Model: 944-021
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 944-021
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699440211
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: S7770 tHb calibration Solution (box of 4 ampoules), for ABL7XX/8XX

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

FDA Product Code

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Product Code	Product Code Name
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
GKF	INSTRUMENT, HEMATOCRIT, AUTOMATED
CGA	GLUCOSE OXIDASE, GLUCOSE
KHP	ACID, LACTIC, ENZYMATIC METHOD
CIG	DIAZO COLORIMETRY, BILIRUBIN
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
JGS	ELECTRODE, ION SPECIFIC, SODIUM
JJS	CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)

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
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8a664a0a-11b0-4b37-87a1-ff96b4da1890
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016