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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 13 of 26
DeviceModel / ReferenceRegistriesClassStatus
Neuroline ConcentricNeurology Needle Electrodes 74025-30/25
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520211041
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520611014
FDA UDI
Class IIActive
Neuroline InojectNeurology Needle Electrodes 74430-36/10
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 523211001
FDA UDI
Class IIActive
SPUR® II Adult Resuscitatorw/Expiratory Filter 30MM 520211048
FDA UDI
Class IIActive
SmartInfuser Set, 5-15ml/hr + Y-Tubing Set 418000501
FDA UDI
Class IIActive
Ambu WhiteSensor WSECG Electrodes WS-00-S/5
FDA UDI
Class IIUnknown
King Mask 1132
FDA UDI
Class IActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530613055
FDA UDI
Class IIActive
Silicone Face Mask 000316000
FDA UDI
Class IActive
Disposable Face Mask 000252953
FDA UDI
Class IActive
aScope™ 4 Cysto 600101000
FDA UDI
Class IIActive
Catheter Set, 140mm Cut-to Size, 4" Introducer 418000534
FDA UDI
Class IIActive
Ambu WhiteSensor 4560MECG Electrodes 4560M
FDA UDI
Class IIUnknown
SPUR® II Adult Resuscitator 520611000E
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531614030
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530613001
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 540212010
FDA UDI
Class IIActive
Oval Silicone ResuscitatorPediatric 370004000
FDA UDI
Class IIUnknown
BlueSensor SUECG Electrodes SU-00-F/60
FDA UDI
Class IIUnknown
Ambu® SPUR® II Adult Resuscitator 523600051
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530614000
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530613800
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520611001
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520611048
FDA UDI
Class IIActive
ACTion Fuser Pump, 200ml, 1-6 ml/hr140mm caut-to-size catheter, 4" int 418111200
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 522611010
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520211010
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530614017
FDA UDI
Class IIActive
AuraOnce 321250000U
FDA UDI
Class IActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544211800
FDA UDI
Class IIUnknown
9013l0203 SC-08-VS/AP/50
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520211010E
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitatorw/CO2 Detector 530615800
FDA UDI
Class IIUnknown
Neuroline InojectNeurology Needle Electrodes 74450-50/10
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530200000
FDA UDI
Class IIActive
ACTion Fuser Pump, 200ml, 1-6 ml/hr, (no catheter) 418203200
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530613800
FDA UDI
Class IIActive
Ambu WhiteSensor 4440ECG Electrodes 4440
FDA UDI
Class IIUnknown
Neuroline 700Neurology Surface Electrodes 70002-K/12
FDA UDI
Class IIUnknown
Ambu® SPUR® II Pediatric Resuscitator 530612001
FDA UDI
Class IIActive
SleepmateVelstretch Band Large, Lt. Grey 813003-100
FDA UDI
Class IIActive
ACTion Block Pump, 650ml, 1-6 ml/hrMultiBolus II 419150650
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530212000
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 521611013
FDA UDI
Class IIActive
Ambu® SureSight® Blade 390531000
FDA UDI
Class IActive
Res-Cue Key Foil Pack 248601101
FDA UDI
Class IIActive
SleepmateAC Body Position Sensor Kit 815600-100
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530600001
FDA UDI
Class IIActive

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