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Ambu A/S

US

Last updated May 24, 2026

Information

Country
US
Address
—
Website
ambuusa.com
LinkedIn
—
Facebook
—
Phone
+14107686464
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
305682023

Catalogue (1294)

Page 5 of 26
DeviceModel / ReferenceRegistriesClassStatus
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523611000
FDA UDI
Class IIActive
King Mask 1232
FDA UDI
Class IActive
King Mask 1145
FDA UDI
Class IActive
BlueSensor BRSECG Electrodes BRS-50-K/US/3
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 524611000
FDA UDI
Class IIActive
Immobilization Kit, with 000281152
FDA UDI
Class IActive
Disposable Face Mask 000252955
FDA UDI
Class IActive
SPUR® II Adult Resuscitatorw/Expiratory Filter 521612048
FDA UDI
Class IIUnknown
AuraGain 408200000
FDA UDI
Class IActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 521611012
FDA UDI
Class IIActive
Snoring Sensor 78 inSleepmate 1420605
FDA UDI
Class IIActive
Neuroline 715Neurology Surface Electrodes 71512-K/C/12
FDA UDI
Class IIActive
SPUR® II Adult Resuscitator 523611031E
FDA UDI
Class IIActive
Ambu® SPUR® II Infant Resuscitator 544216031
FDA UDI
Class IIActive
Mark IV Baby Resuscitator 299005000
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 523611054
FDA UDI
Class IIActive
BlueSensor QRECG Electrodes QR-50-A/10
FDA UDI
Class IIUnknown
SleepmatePiezo Crystal Sensor & Band, Infant/Ped, Velcro Tab 813255-100
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorMask Lg. Adult, Exhalation Filter 520612048
FDA UDI
Class IIUnknown
Neuroline 715Neurology Surface Electrodes 71505-K/C/12
FDA UDI
Class IIActive
ACTion Fuser Pump, 200ml, 1-6 ml/hr190mm caut-to-size catheter 418107200
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 540200031
FDA UDI
Class IIActive
SleepmateThermistor AirFlow Sensor 814940-100
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544211031
FDA UDI
Class IIActive
Mark III MIL Resuscitatorwith butyl rubber outer cover and Mark III pa A233004000I
FDA UDI
Class IIActive
King Mask 2055
FDA UDI
Class IActive
Ambu® SPUR® II Adult Resuscitator 523211000
FDA UDI
Class IIActive
Ambu WhiteSensor 4440 4440/3
FDA UDI
Class IIUnknown
BlueSensor QECG Electrodes Q-00-A/25
FDA UDI
Class IIUnknown
Neuroline Cup 72610-M/25
FDA UDI
Class IIActive
King Mask 2065
FDA UDI
Class IActive
Snoring Sensor 1.5mm ConnectorSleepmate 1420610
FDA UDI
Class IIUnknown
BLUE MAXMortara Instrument SU-00-C/BUR/100
FDA UDI
Class IIUnknown
Ambu® SPUR® II Adult Resuscitator 520611700
FDA UDI
Class IIActive
Mark III MIL Resuscitatorwith butyl rubber outer cover and Mark III pa A233006000
FDA UDI
Class IIUnknown
Oval Silicone ResuscitatorPediatric 370002000
FDA UDI
Class IIUnknown
Ambu® SPUR® II Adult Resuscitator 523211016
FDA UDI
Class IIActive
Neuroline Twisted Pair SubdermalNeurology Needle Electrodes 74612-250/2/20
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544212001
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530615031
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531631000
FDA UDI
Class IIUnknown
Neuroline MonopolarNeurology Needle Electrodes 74225-36/40
FDA UDI
Class IIActive
Ambu® ACTion™ Block Pump 419111000C
FDA UDI
Class IIActive
King Mask 1345
FDA UDI
Class IActive
Neuroline Cup 72615-M/23
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520611034
FDA UDI
Class IIActive
SPUR® II Adult Resuscitatorw/CO2 Detector and Mercury Filter 523611717
FDA UDI
Class IIUnknown
Oval Silicone ResuscitatorAdult, with pop off valve 470002100
FDA UDI
Class IIUnknown
Neuroline Cup 72620-M/23
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523611031
FDA UDI
Class IIActive

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