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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 4 of 26
DeviceModel / ReferenceRegistriesClassStatus
aBox Duodeno 485001000US
FDA UDI
Class IIActive
ACTion Fuser Pump, 200ml, 1-6 ml/hr140mm caut-to-size catheter 418103200
FDA UDI
Class IIActive
BlueSensor BRECG Electrodes BR-50-A/12
FDA UDI
Class IIUnknown
Ambu® SPUR® II Adult Resuscitator 520211061
FDA UDI
Class IIActive
BlueSensor NFECG Electrodes NF-00-F/12
FDA UDI
Class IIUnknown
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530213011
FDA UDI
Class IIActive
AuraOnce 321400000U
FDA UDI
Class IActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 540211057
FDA UDI
Class IIUnknown
BlueSensor RECG Electrodes R-00-S/3
FDA UDI
Class IIActive
ACTion Block Pump, 400ml, 5-15 ml/hr 418202400
FDA UDI
Class IIActive
Aura40 326400000U
FDA UDI
Class IActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530613001
FDA UDI
Class IIActive
AuraOnce 321200000U
FDA UDI
Class IActive
T-FlowSplitter 418000505
FDA UDI
Class IIActive
Silicone Face Mask 000317000
FDA UDI
Class IActive
SleepmateInductance Belt Thorax Kit, Pediatric 819002-100
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530214000B
FDA UDI
Class IIActive
Mark IV Baby Resuscitator 299008000
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530600000
FDA UDI
Class IIActive
Perfit Collar™ 000264501
FDA UDI
Class IActive
Neuroline SubdermalNeurology Needle Electrodes 74512-150/24
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544216069
FDA UDI
Class IIActive
ACTion Block Pump, 400ml, 5-15 ml/hrMultiBolus II 419151400
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530612800
FDA UDI
Class IIActive
AuraFlex 327200000U
FDA UDI
Class IActive
SleepmateRIPmate Kit with Disposable Bands - A5 819200-121
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 540216030
FDA UDI
Class IIActive
ACTion Block Pump, 400ml, 5-15 ml/hr, Splitter 418203400
FDA UDI
Class IIActive
Res-Cue Key Face Shield 248201102
FDA UDI
Class IIUnknown
Ambu® SPUR® II Adult Resuscitator 523611030
FDA UDI
Class IIActive
SleepmateAC Model (snoring & flow), includes 5 Nasal + Cannulas 814330-100
FDA UDI
Class IIUnknown
Ambu® ACTion™ Block Pump 419110650C
FDA UDI
Class IIActive
Aura40 326250000U
FDA UDI
Class IActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520600000
FDA UDI
Class IIActive
SPUR® II PEDI. BAG RESVR.w/CO2 Detector 530213800
FDA UDI
Class IIActive
Neuroline Twisted Pair SubdermalNeurology Needle Electrodes 74612-150/1/20
FDA UDI
Class IIActive
SleepmateInductance Belt Thorax Kit, Infant 819011-100
FDA UDI
Class IIUnknown
SmartInfuser Set, 5-15ml/hr, with MultiBolus 418000519
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 523611061
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530619000
FDA UDI
Class IIActive
Neuroline 715 71505-M/C/12
FDA UDI
Class IIActive
aScope™ 2Flexible Intubation Scope 400002005
FDA UDI
Class IIUnknown
Ambu® aScope™ 5 Cysto HD 603101000
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 523611051
FDA UDI
Class IIActive
Ambu® ACTion™ Fuser Pump 418108200M
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 523611031
FDA UDI
Class IIActive
BlueSensor NECG Electrodes N-00-S/25
FDA UDI
Class IIActive
BlueSensor VLCECG Electrodes VLC-00-S/10
FDA UDI
Class IIActive
SleepmateThermocouple, Infant / Pediatric 814805-100
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530233000
FDA UDI
Class IIActive

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