Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

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 18 of 26
DeviceModel / ReferenceRegistriesClassStatus
SleepmateCannuTherm Kit (CannuTherm & 5 Nasal Cannulas) 814310-100
FDA UDI
Class IIActive
Ambu® SPUR® II Infant Resuscitator 544212000
FDA UDI
Class IIActive
SleepmatePiezo Crystal Sensor & Band, Adult/Ped, Double Loop 813246-100
FDA UDI
Class IIActive
Aura-i 329100000U
FDA UDI
Class IActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531615010
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530615000
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorMASK.INF.W/10' O2 & MANOMETER 544212016
FDA UDI
Class IIActive
Ambu WhiteSensor 4300ECG Electrodes 4300
FDA UDI
Class IIUnknown
King Mask 1423
FDA UDI
Class IActive
BlueSensor NECG Electrodes N-00-A/25
FDA UDI
Class IIActive
SleepmateBody Position - Cadwell 815030-000
FDA UDI
Class IIUnknown
Ambu® ACTion™ Block Pump 419151650C
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520211000E
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530218047
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520211001
FDA UDI
Class IIActive
SPUR® Adult Resuscitator 520611048E
FDA UDI
Class IIActive
Ambu® ACTion™ Fuser Pump 418103400C
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530611000
FDA UDI
Class IIActive
BlueSensor QECG Electrodes Q-10-A/25
FDA UDI
Class IIUnknown
Ambu® SureSight® Blade 390231000
FDA UDI
Class IActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544200000
FDA UDI
Class IIActive
Neuroline ConcentricNeurology Needle Electrodes 74030-35/25
FDA UDI
Class IIActive
BlueSensor PECG Electrodes P-00-S/10
FDA UDI
Class IIActive
SleepmateRIPmate Inductance Kit 819110-100
FDA UDI
Class IIActive
SmartInfuser Set, 1-6ml/hr, with MultiBolus 418000511
FDA UDI
Class IIActive
aScope™ 5 Broncho HD 5.0/2.2 Sampler Set 621002000US
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544211030
FDA UDI
Class IIActive
Catheter Set, 140mm Cut-to Size (920mm tube) 6" Introducer 418000543
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544212000
FDA UDI
Class IIActive
SPUR® II Infant Resuscitatorw/CO2 Detector & Manometer 540212830
FDA UDI
Class IIActive
ACTion Fuser Pump, 200ml, 5-15 ml/hrMultiBolus, 140mm caut-to-size cat 418102400
FDA UDI
Class IIActive
Ambu WhiteSensor 4440MECG Electrodes 4440M
FDA UDI
Class IIUnknown
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 521612000
FDA UDI
Class IIActive
SPUR® Pediatric Resuscitator 530613051
FDA UDI
Class IIActive
ACTion™ Block Pump, 1000ml, 5-15 ml/hr, Clamp 419111000
FDA UDI
Class IIActive
BlueSensor SPECG Electrodes SP-00-S/4
FDA UDI
Class IIActive
ACTion Fuser Pump, 400ml, 1-6 ml/hr, (no catheter) 418204400
FDA UDI
Class IIActive
SleepmateAASM CannuTherm Flow Kit (AC AirFlow Pressure, Reusable Therm 814360-100
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530614030
FDA UDI
Class IIActive
Ambu WhiteSensor 0215M BIOTABSECG Electrodes 0215M
FDA UDI
Class IIUnknown
ACTion Block Pump, 650ml, 1-6 ml/hr 419105650
FDA UDI
Class IIActive
SPUR® II INFANT TUBE RESVR.w/CO2 Detector 544212800
FDA UDI
Class IIActive
SPUR® Adult Resuscitator 521611061
FDA UDI
Class IIActive
aScope™ Duodeno 482001000
FDA UDI
Class IIActive
BlueSensor VLECG Electrodes VL-00-S/10
FDA UDI
Class IIActive
SPUR® II Adult Resuscitator 523631051
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitatorw/Expiratory Filter 530214034
FDA UDI
Class IIActive
SleepmateVelstretch Band Infant, Royal Blue 813004-100
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530215000B
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520611600
FDA UDI
Class IIUnknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.