FDA.reportPublic FDA data

Expiratory heater, SERVO DuoGuard

Primary DI
07325710002728
Brand
Expiratory heater, SERVO DuoGuard
Company
Maquet Critical Care AB
Model
6693732
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IRQUnit, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRQUnit, Heating, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07325710002728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07325710002728073257100027287325710002728

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit condenserA portable, mains electricity (AC-powered) device designed to be integrated within the expiratory limb of a ventilator breathing circuit to remove excess moisture through cooling and condensing, whilst also reheating the dried gases to an appropriate ventilator-compatible temperature. It includes a heat exchanger and may include disposable condensate collection devices (e.g., cartridge, collection bag). It is intended to prevent condensation from forming within the expiratory limb and ventilator (rain-out).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
632707092
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07325710011140ITS HousingPV404668827732026-03-24
07325710011607PiCCO catheterPV2015L2068850492026-03-24
07325710017043PiCCO catheterPV2013L0768850442026-03-24
07325710017067PiCCO catheterPV2014L1668850462026-03-24
07325710017098PiCCO catheterPV2014L0868850452026-03-24
07325710017104PiCCO catheterPV2014L2268850472026-03-24
07325710012673Drawer for Low mobile carts68903652023-12-10
07325710001653Compressor Mini 115V 60Hz64817792023-09-21
07325710015117Servo-air Lite68932002023-09-21
07325710010518Base Unit Servo-u MR68888002021-12-01
07325710012185Heliox Servo adapter kit68894872021-06-18
07325710001189Air inlet filter68824082020-09-16
07325710003114Base unit, Servo-air68820002020-09-16
07325710003909Battery module68826072020-09-16
07325710004159Mobile Cart, Flat Pack Servo-air68819992020-09-16
07325710004166Shelf base, Servo-air68820022020-09-16
07325710004210Support arm 17968820012020-09-16
07325710004906Cabinet68820742020-09-16
07325710011331Humidifier holder for rail 10 x 25/10 x 30 mm65451102020-09-16
17325710004248Dust filter 20 pcs/pkg68834412020-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898966442933IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIRQ2025-02-25
07898966442964IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIRQ2025-02-25
00092237626009HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-05-14
00092237626016HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-05-14
00092237625545HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625552HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625569HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625576HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625583HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625590HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625606HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625613HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625620HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625637HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625644HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625651HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625668HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625675HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625460HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625477HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625484HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625491HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625507HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625514HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625521HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625538HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625439HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-01
00092237625354HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-02-29
00092237625361HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-02-29
00092237625378HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-02-29