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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 6 of 26
DeviceModel / ReferenceRegistriesClassStatus
SleepmateVelstretch Band Small, Lt. Blue 813001-100
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitatorw/Inspiratory Filter & Manometer 530613054
FDA UDI
Class IIActive
Oval Silicone Resuscitator, Neonate A288003000
FDA UDI
Class IIUnknown
ACTion Fuser Pump, 200ml, 1-6 ml/hrDual 140mm caut-to-size catheter 418108200
FDA UDI
Class IIActive
SPUR® II Adult Resuscitatorw / Pressure Limiting Valve and expiratory 524611017
FDA UDI
Class IIUnknown
Head Wedge™ 000264036
FDA UDI
Class IActive
Ambu WhiteSensor WSP30 WSP30-00-S/3
FDA UDI
Class IIUnknown
Ambu® SPUR® II Adult Resuscitator 520211071
FDA UDI
Class IIActive
SPUR® II Adult Resuscitatorw/CO2 Detector 521611700
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520614000
FDA UDI
Class IIActive
SleepmatePiezo Limb Sensor - Replacement 817230-100
FDA UDI
Class IIActive
Silicone Face Mask 000315000
FDA UDI
Class IActive
Ambu® SPUR® II PEDI. BAG RESVR. 530213800
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520611000
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544216000
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520612000
FDA UDI
Class IIActive
Neuroline SubdermalNeurology Needle Electrodes 74512-150/24W
FDA UDI
Class IIUnknown
VivaSight™ 2 DLT Kit 39 Fr - LEFT 412391000
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520217000
FDA UDI
Class IIActive
SleepmatePiezo Crystal Sensor & Band, Adult/Ped, Double Buckle, Alice 813206-119
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitatorw/Manometer 530619016
FDA UDI
Class IIActive
Neuroline 720Neurology Surface Electrodes 72010-K/C/12
FDA UDI
Class IIActive
Ambu® SPUR® II Infant Resuscitator 540212031
FDA UDI
Class IIActive
SleepmateVelstretch Band Kit, Adult 813013-100
FDA UDI
Class IIActive
Perfit Collar™ 000264206
FDA UDI
Class IActive
SleepmateRIPmate A5 Thorax Processor 819170-000
FDA UDI
Class IIActive
SleepmateQDC Viasys Sum Belt Kit (2) 819100-100
FDA UDI
Class IIUnknown
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531612035
FDA UDI
Class IIActive
aScope™ 4 Broncho Large 5.8/2.8 478001000
FDA UDI
Class IIActive
Oval Silicone Resuscitator, Neonate A288004000
FDA UDI
Class IIUnknown
Ambu® SPUR® II Adult Resuscitator 521611000
FDA UDI
Class IIActive
SleepmateRIPmate Inductance Belt, Abdomen 819140-100
FDA UDI
Class IIActive
BlueSensor NFECG Electrodes NF-10-SC/12
FDA UDI
Class IIUnknown
AuraGain 408600000
FDA UDI
Class IActive
Ambu® SPUR® II Adult Resuscitator 524614000
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530614000
FDA UDI
Class IIActive
Reusable PEEP 10 valve A137001000
FDA UDI
Class IIActive
SleepmateSnoring Microphone 812500-000
FDA UDI
Class IIActive
BlueSensor RECG Electrodes R-00-S/10
FDA UDI
Class IIActive
SleepmateThermocouple, PL 00103750
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530215000
FDA UDI
Class IIActive
ACTion Fuser Pump, 400ml, 1-6 ml/hrDual 190mm caut-to-size catheter 418113400
FDA UDI
Class IIActive
ACTion Block Pump, 400ml, 1-6 ml/hrMultiBolus II 419150400
FDA UDI
Class IIActive
Res-Cue KeyFace Shield 248303102
FDA UDI
Class IIUnknown
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 521611038
FDA UDI
Class IIActive
Compression Unit Set, 200 ml, with Clamp 418000200
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530612000
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 523632016
FDA UDI
Class IIActive
Single Patient Use Resuscitator 531613051
FDA UDI
Class IIActive
Ambu® ACTion™ Block Pump 419150400C
FDA UDI
Class IIActive

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