ABL80 FLEX Analyzer 393-839

GUDID 05700693938394

ABL80 FLEX Full panel, Analyzer

Radiometer Medical ApS

Metabolic profile clinical chemistry analyser IVD, portable, automated
Primary Device ID05700693938394
NIH Device Record Key9864d2f6-eda4-415e-8462-8b05d404db00
Commercial Distribution StatusIn Commercial Distribution
Brand NameABL80 FLEX Analyzer
Version Model Number393-839
Catalog Number393-839
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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
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

Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile

Device Identifiers

Device Issuing AgencyDevice ID
GS105700693938394 [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

Devices Manufactured by Radiometer Medical ApS

55700699428986 - SAFE CLINITUBES D957P-70-70X12024-07-09 D957P-70-70x1 safeCLINITUBES Blood Sampler Multipack with heparinized plastic capillaries and accessories. 70 µL, 1 vial of 250
05700699460509 - SC90 50 BG, LYT, MET, OXI + QC2024-07-09 SC90 50 BG, LYT, MET, OXI + QC
55700699428764 - CLINITUBES D941G-NA-240-85X102023-04-20 D941G-NA-240-85x10 CLINITUBES 10 vials of 75 units, Multipack
55700699044391 - CAPILLARY CAPS, RED 160pcs.2022-12-13 Capillary Caps, Red bag of 160 units
55700699044537 - CAPILLARY CAPS, green 110pcs.2022-12-13 Capillary Caps, Green bag of 110 units
55700699056615 - CLINITUBES D956G-70-35*12022-12-13 D956G-70-35x1 CLINITUBES 1 vial of 75 units. 35 µL. Multipack w. accessories
55700699060223 - ABL77 CAPILLARY ADAPTERS2022-12-13 Capillary adaptor vented, 100 pcs. for ABL77
05700699339393 - AQURE NT Premium2022-12-13 AQURE NT Premium

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.