MOBILE CART

GUDID 07325710000786

Maquet Critical Care AB

Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator Neonatal/adult intensive-care ventilator
Primary Device ID07325710000786
NIH Device Record Keyf6ccd4eb-4880-4c32-ac54-3179588b432d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMOBILE CART
Version Model Number6693695
Company DUNS632707092
Company NameMaquet Critical Care AB
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107325710000786 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBKVentilator, Continuous, Facility Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-28
Device Publish Date2016-01-28

Devices Manufactured by Maquet Critical Care AB

07325710012673 - Drawer for Low mobile carts2023-12-18
07325710001653 - Compressor Mini 115V 60Hz2023-09-29
07325710015117 - Servo-air Lite2023-09-29
07325710010518 - Base Unit Servo-u MR2021-12-09
07325710012185 - Heliox Servo adapter kit2021-06-28
07325710001189 - Air inlet filter2020-09-24
07325710003114 - Base unit, Servo-air2020-09-24
07325710003909 - Battery module2020-09-24

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