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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 21 of 26
DeviceModel / ReferenceRegistriesClassStatus
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 522611010
FDA UDI
Class IIActive
Ambu® SPUR® II Infant Resuscitator 544211047
FDA UDI
Class IIActive
SPUR® II Adult Resuscitatorw/Mercury Filter 523611051
FDA UDI
Class IIActive
ECG Electrodes 0315M/FANT
FDA UDI
Class IIUnknown
Immobilization Kit, with 000281151
FDA UDI
Class IActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531614026
FDA UDI
Class IIActive
BlueSensor VLECG Electrodes VL-00-S/25
FDA UDI
Class IIActive
Sleepmate / SparepartLuer to O2 connector 814340-000
FDA UDI
Class IIActive
Disposable Face Mask 000252956
FDA UDI
Class IActive
AuraOnce 321300000U
FDA UDI
Class IActive
ACTion Block Pump, 650ml, 5-15 ml/hr, MultiBolus 419101650
FDA UDI
Class IIActive
Body Position Sensor - Alice 3 815000-119
FDA UDI
Class IIUnknown
BlueSensor BRSECG Electrodes BRS-50-K/C3/3
FDA UDI
Class IIUnknown
Perfit Collar™ 000264205
FDA UDI
Class IActive
King Mask 1065
FDA UDI
Class IActive
SleepmateInductance Belt Abdomen Kit, Adult - Alice 5 819013-121
FDA UDI
Class IIActive
SleepmateThermistor w. safety pins 814900-100
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 521611037
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitatorw/PEEP Valve 20, Manometer & CO2 Detect 530613831
FDA UDI
Class IIActive
Aura40 326150000U
FDA UDI
Class IActive
SPUR® II Adult Resuscitatorw/Expiratory Filter 521611048
FDA UDI
Class IIActive
Disposable Face Masks 000252053
FDA UDI
Class IActive
Mark IV Baby Resuscitator 299001000
FDA UDI
Class IIActive
Ambu® ACTion™ Block Pump 418202400C
FDA UDI
Class IIActive
SPUR® II Infant Resuscitatorw/PEEP Valve 20 & Manometer 544212047
FDA UDI
Class IIActive
Ambu WhiteSensor 4242 4242-00-S/5
FDA UDI
Class IIUnknown
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530213000B
FDA UDI
Class IIActive
King Mask 1012
FDA UDI
Class IActive
SleepmateKit, Z4 Lead 11626
FDA UDI
Class IIUnknown
Ambu® SPUR® II Pediatric Resuscitator 531615010
FDA UDI
Class IIActive
aScope™ 4 Cysto 601177000
FDA UDI
Class IIUnknown
SleepmateRIPmate Inductance Kit, Pediatric 819102-100
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 521611010
FDA UDI
Class IIActive
Neuroline 720Neurology Surface Electrodes 72001-K/12
FDA UDI
Class IIActive
SleepmateDisposable RIP Bands 819201-000
FDA UDI
Class IIActive
aScope™ 4 Broncho Regular 5.0/2.2 477101000
FDA UDI
Class IIActive
Ambu Neuroline Monopolar CableLength of leadwire: 76 cm (30") 1744
EUDAMEDFDA UDI
Class IIActive
Neuroline Cup 72615-M/27
FDA UDI
Class IIActive
Neuroline Cup 72610-M/23
FDA UDI
Class IIActive
Ambu® ACTion™ Fuser Pump 418103400M
FDA UDI
Class IIActive
SPUR® Adult Resuscitator 520612061
FDA UDI
Class IIActive
Neuroline 700Neurology Surface Electrodes 70020-K/C/4
FDA UDI
Class IIActive
Neuroline 710Neurology Surface Electrodes 71010-K/12
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530214034
FDA UDI
Class IIActive
Ambu WhiteSensor WS WS-00-S/RT/3
FDA UDI
Class IIUnknown
Neuroline GroundNeurology Surface Electrodes 71410-M/1
FDA UDI
Class IIActive
AuraStraight 324400000U
FDA UDI
Class IActive
BlueSensor NECG Electrodes N-50-A/25
FDA UDI
Class IIUnknown
King Mask 2012
FDA UDI
Class IActive
Ambu WhiteSensor 0615M BIOTABSECG Electrodes 0615M
FDA UDI
Class IIUnknown

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