Calibration Solution 943-837

GUDID 05700699438379

S1545 Calibration Solution 1 pH 7.383, 140 mL. For ABL5, BPH5

Radiometer Medical ApS

Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator Multiple blood gas analyte IVD, calibrator
Primary Device ID05700699438379
NIH Device Record Key88bf35e0-3789-44c7-8842-9f3c7cec76ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalibration Solution
Version Model Number943-837
Catalog Number943-837
Company DUNS308667539
Company NameRadiometer Medical ApS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105700699438379 [Primary]

FDA Product Code

CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-01

On-Brand Devices [Calibration Solution]

057006994406931100 CALPACK Calibration Solution for ABL77
05700699440648S1720 Calibration Solution 1 200 mL, for ABL7XX.
05700699440259S1730 Calibration Solution 2 200 mL, for ABL7XX
05700699440242S1720 Calibration Solution 1 200 mL, for ABL7XX
05700699440211S7770 tHb calibration Solution (box of 4 ampoules), for ABL7XX/8XX
05700699438393S1555 Calibration Solution 2 pH 6.841, 140 mL. For ABL5, BPH5
05700699438379S1545 Calibration Solution 1 pH 7.383, 140 mL. For ABL5, BPH5

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