Breath syst 15mm HME & MR 3M Disp

GUDID 17325710002299

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 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 ID17325710002299
NIH Device Record Keyb035515d-d648-4a2b-99e4-7cd6b84dc69b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBreath syst 15mm HME & MR 3M Disp
Version Model Number6694140
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
GS107325710002292 [Primary]
GS117325710002299 [Package]
Contains: 07325710002292
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

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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