Calibration Solution 944-069

GUDID 05700699440693

1100 CALPACK Calibration Solution for ABL77

Radiometer Medical ApS

Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Primary Device ID05700699440693
NIH Device Record Key46ff0ee4-7d09-4d6d-bc00-004329716c61
Commercial Distribution Discontinuation2018-04-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCalibration Solution
Version Model Number944-069
Catalog Number944-069
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 12 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105700699440693 [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 Number3
Public Version Date2018-06-01
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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