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Ambu A/S

US

Last updated May 24, 2026

Information

Country
US
Address
—
Website
ambuusa.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+14107686464
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
305682023

Catalogue (1294)

Page 20 of 26
DeviceModel / ReferenceRegistriesClassStatus
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530212025
FDA UDI
Class IIActive
ACTion Block Pump, 400ml, 1-6 ml/hr 418201400
FDA UDI
Class IIActive
King Mask 1245
FDA UDI
Class IActive
BlueSensor BRECG Electrodes BR-50-K/US/3
FDA UDI
Class IIActive
SleepmateOne Channel Thermistor, Infant (Cable, Interface & 10 sensors 814901-000
FDA UDI
Class IIActive
AuraGain 408400000
FDA UDI
Class IActive
SPUR® Infant Resuscitator 540212061
FDA UDI
Class IIActive
Single Patient Use Resuscitator 530613061
FDA UDI
Class IIActive
SPUR® Adult Resuscitator 520211061E
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 531614000
FDA UDI
Class IIActive
Neuroline CupNeurology Surface Electrodes 72610-M/10
FDA UDI
Class IIActive
BlueSensor 2300ECG Electrodes BS-TAB-2300/100
FDA UDI
Class IIUnknown
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 540211031
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531613047
FDA UDI
Class IIActive
AuraGain 408250000
FDA UDI
Class IActive
BlueSensor PECG Electrodes P-00-S/12
FDA UDI
Class IIUnknown
Ambu® SPUR® II Pediatric Resuscitator 530639011
FDA UDI
Class IIActive
Ambu WhiteSensor 7841PECG Electrodes 7841P
FDA UDI
Class IIUnknown
Ambu® SPUR® II Pediatric Resuscitator 531614051
FDA UDI
Class IIActive
AuraFlex 327300000U
FDA UDI
Class IActive
Oval Silicone ResuscitatorAdult 470001000
FDA UDI
Class IIUnknown
Ambu® SPUR® II Adult Resuscitator 520211034
FDA UDI
Class IIActive
SPUR® Adult Resuscitator 523211017
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520212001
FDA UDI
Class IIActive
SleepmateCannuTherm - Reusable Thermal Sensor 814840-100
FDA UDI
Class IIActive
SPUR® II Adult Resuscitatorw/Expiratory Filter & Manometer 523611017
FDA UDI
Class IIActive
King Mask K1122
FDA UDI
Class IActive
Ambu WhiteSensor CMMECG Electrodes CMM-00-S/30
FDA UDI
Class IIUnknown
SleepmateCannuTherm Thermistor 814960-100
FDA UDI
Class IIActive
SPUR® Adult Resuscitator 524611048
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530213011
FDA UDI
Class IIActive
SleepmateSnoring Microphone - Alice 3 812500-019
FDA UDI
Class IIActive
Neuroline MonopolarNeurology Needle Electrodes 74250-45/40
FDA UDI
Class IIActive
Ambu WhiteSensor 4200ECG Electrodes 4200
FDA UDI
Class IIUnknown
Regulating Set 5-15 with parallel MultiBolus IIStand alone, complement 418000540
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 531614026
FDA UDI
Class IIActive
aScope™ 4 Cysto 601005000
FDA UDI
Class IIActive
SleepmateRIPmate 1" wide Belt Kit - Adult 819160-000
FDA UDI
Class IIActive
Disposable Face Mask 000252954
FDA UDI
Class IActive
SleepmateDC Body Position Sensor - Cadwell 815700-004
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 531613031
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 521611000
FDA UDI
Class IIActive
Disposable PEEP 20 valve 199002001
FDA UDI
Class IIActive
King Mask 1022
FDA UDI
Class IActive
Ambu WhiteSensor 4500M 4500M/5
FDA UDI
Class IIUnknown
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531600000
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530200000
FDA UDI
Class IIActive
SleepmateThermocouple Airflow - 90 cm 814860-100
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530217000B
FDA UDI
Class IIUnknown
BlueSensor NEOXECG Electrodes NEOX-60-K/US/3
FDA UDI
Class IIActive

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