Breath syst 10mm HME Disp1.2m

GUDID 17325710002428

Maquet Critical Care AB

Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use Ventilator breathing circuit, single-use
Primary Device ID17325710002428
NIH Device Record Key3f3c23ef-1ba1-4548-804d-308f468e913c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBreath syst 10mm HME Disp1.2m
Version Model Number6694105
Company DUNS632707092
Company NameMaquet Critical Care AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107325710002421 [Primary]
GS117325710002428 [Package]
Contains: 07325710002421
Package: [20 Units]
In Commercial Distribution

FDA Product Code

BZOSet, Tubing And Support, Ventilator (W Harness)
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2015-10-30

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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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