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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 12 of 26
DeviceModel / ReferenceRegistriesClassStatus
Ambu WhiteSensor 7841P 7841P/3
FDA UDI
Class IIUnknown
Ambu® SPUR® II Adult Resuscitator 521611071
FDA UDI
Class IIActive
Neuroline 710Neurology Surface Electrodes 71001-SC/12
FDA UDI
Class IIActive
King Mask 1055
FDA UDI
Class IActive
SPUR® II Pediatric Resuscitatorw/Hudson Connector 531600045
FDA UDI
Class IIActive
Ambu® ACTion™ Block Pump 419105650C
FDA UDI
Class IIActive
AuraStraight 324200000U
FDA UDI
Class IActive
Neuroline 700Neurology Surface Electrodes 70001-SC/12
FDA UDI
Class IIActive
Ambu WhiteSensor 0315M BIOTABSECG Electrodes 0315M
FDA UDI
Class IIUnknown
SPUR® Pediatric Resuscitator 530213061
FDA UDI
Class IIActive
AuraStraight 324250000U
FDA UDI
Class IActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520616000
FDA UDI
Class IIActive
SleepmateThermistor cable / Multi UARS 814400-100
FDA UDI
Class IIActive
SPUR® II Adult Resuscitatorw / Pressure Limiting Valve 524611031
FDA UDI
Class IIActive
Neuroline InojectNeurology Needle Electrodes 74475-55/10
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530618000
FDA UDI
Class IIActive
Ambu aView™ 2 Advance 405011000US1
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitatorw/Nellcor CO2 Detector 530613801N
FDA UDI
Class IIUnknown
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 521611037
FDA UDI
Class IIActive
BlueSensor NECG Electrodes N-50-F/25
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530213001B
FDA UDI
Class IIUnknown
ACTion Block Pump, 200ml, 1-6 ml/hr 418201200
FDA UDI
Class IIActive
Airflow Thermistor 78 inSleepmate 1420435
FDA UDI
Class IIActive
aView™ Monitor 405002000
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorPop-off open 40", w/PEEP Valve 20 524611001
FDA UDI
Class IIActive
Neuroline 710Neurology Surface Electrodes 71015-K/C/12
FDA UDI
Class IIActive
Res-Cue Key Face Shield 248201103
FDA UDI
Class IIUnknown
Ambu® SPUR® II Adult Resuscitator 520212033
FDA UDI
Class IIActive
Neuroline 710Neurology Surface Electrodes 71010-J/12
FDA UDI
Class IIActive
SleepmatePiezo Limb Sensor Kit (two limbs) 817220-100
FDA UDI
Class IIActive
Mark IV Resuscitatorwith single shutter patient valve 304002000
FDA UDI
Class IIActive
VivaSight™ 2 DLT Kit 35 Fr - LEFT 412351000
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitatorw/Manometer 530213030
FDA UDI
Class IIActive
Oval Silicone ResuscitatorAdult, with pop off valve 470003100
FDA UDI
Class IIUnknown
Neuroline 700Neurology Surface Electrodes 70002-SC/12
FDA UDI
Class IIActive
BlueSensor TECG Electrodes T-00-S/10
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 521611012
FDA UDI
Class IIActive
SleepmateThermocouple (Adult) 69329
FDA UDI
Class IIUnknown
Ambu® SPUR® II Pediatric Resuscitator 531611000
FDA UDI
Class IIActive
SleepmateRIPmate Belt - Adult 1-1/2" Band (26-65") 819103-000
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 531615000
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520217000
FDA UDI
Class IIActive
Ambu WhiteSensor WSECG Electrodes WS-00-S/RT/50
FDA UDI
Class IIUnknown
9013s0212 70001-SC/AP/12
FDA UDI
Class IIActive
Neuroline 720Neurology Surface Electrodes 72000-S/25
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530635031
FDA UDI
Class IIActive
SleepmateRIPmate Cable - 50 cm 819151-000
FDA UDI
Class IIActive
Perfit Collar™ 000264504
FDA UDI
Class IActive
Ambu WhiteSensor WSECG Electrodes WS-00-S/10
FDA UDI
Class IIUnknown
Mark IV Resuscitatorwith single shutter patient valve 304001000
FDA UDI
Class IIActive

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