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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 2 of 26
DeviceModel / ReferenceRegistriesClassStatus
SPUR® II Pediatric Resuscitatorwith Filter 531613017
FDA UDI
Class IIActive
SleepmateOne Channel Thermistor, Medium (Cable, Interface & 10 sensors 814902-000
FDA UDI
Class IIUnknown
Ambu® ACTion™ Fuser Pump 418108200C
FDA UDI
Class IIActive
Ambu WhiteSensor WSECG Electrodes WS-00-S/30
FDA UDI
Class IIUnknown
Mark IV Baby Resuscitator 299006000
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530613034
FDA UDI
Class IIActive
Catheter Set, 190mm Cut-to Size, 9" Introducer + FlowSplitter 418000544
FDA UDI
Class IIActive
SmartInfuser Set, 5-15 ml/hr 418000506
FDA UDI
Class IIActive
Compression Unit Set, 650ml, with Clamp 418000650
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530213010
FDA UDI
Class IIActive
AuraStraight 324300000U
FDA UDI
Class IActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531617000
FDA UDI
Class IIUnknown
Ambu® SPUR® II Pediatric Resuscitator 530618000
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 521611001
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530612800
FDA UDI
Class IIActive
Ambu WhiteSensor WSP30 WSP30-00-S/5
FDA UDI
Class IIUnknown
Sleepmate / SparepartBreathoprene Ankle Band, pair 817000-000
FDA UDI
Class IIActive
Ambu® SPUR® II Infant Resuscitator 540216030
FDA UDI
Class IIActive
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531612000
FDA UDI
Class IIActive
Neuroline SubdermalNeurology Needle Electrodes 74512-100/24
FDA UDI
Class IIUnknown
Ambu® SPUR® II Infant Resuscitator 540211030
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 531613030
FDA UDI
Class IIActive
Ambu® SPUR® II Infant Resuscitator 540211031
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530213000B
FDA UDI
Class IIActive
SPUR® II Adult Resuscitator 521611071
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544212010
FDA UDI
Class IIActive
Redi-ACE - Mini 472004000
FDA UDI
Class IActive
Ambu® SPUR® II Adult Resuscitator 524611047
FDA UDI
Class IIActive
ACTion Fuser Pump, 400ml, 1-6 ml/hrDual 140mm caut-to-size catheter 418108400
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530212025
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 531613055
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitatorw/10' 02 tube & Manometer 530200016
FDA UDI
Class IIActive
SPUR® II Infant Resuscitatorw/Expiratory Filter 540212049
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520212000
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorMask Md. Adult, Exhalation Filter 520611048
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520214000E
FDA UDI
Class IIActive
SPUR® II Adult Resuscitatorw/Expiratory Filter 30MM 521611049
FDA UDI
Class IIActive
SleepmateUARS Starter Kit (Cable interface & 5 Sensors) 816400-100
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 522631000
FDA UDI
Class IIUnknown
SPUR® II Infant Resuscitator 540216047
FDA UDI
Class IIActive
BLUE MAXMortara Instrument Q-00-S/BUR/25
FDA UDI
Class IIUnknown
Ambu® SPUR® II Pediatric Resuscitator 530613071
FDA UDI
Class IIActive
Ambu® SureSight® Blade 390211000
FDA UDI
Class IActive
SPUR® II Adult Resuscitatorw/Expiratory Filter 520611066
FDA UDI
Class IIActive
Mark IV Resuscitatorwith single shutter patient valve 304007000
FDA UDI
Class IIActive
Neuroline 710Neurology Surface Electrodes 71015-K/12
FDA UDI
Class IIActive
SleepmateBody Position Sensor - Alice 5 815000-121
FDA UDI
Class IIUnknown
BlueSensor VLECG Electrodes VL-00-A/25
FDA UDI
Class IIUnknown
Ambu® SPUR® II Infant Resuscitator 540212030
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 523611730
FDA UDI
Class IIActive

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