Ambu Inc

FDA Filings

This page includes the latest FDA filings for Ambu Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Ambu Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1220828
FEI Number1121788
NameAMBU INC.
Owner & OperatorAMBU A/S
Contact Address13 BALTORPBAKKEN --
BALLERUP DK-NOTA DK-2750 DK
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address6230 Old Dobbin Ln Ste 250
Columbia, MD 21045 US

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
AMBU, INC.
AMBU NEUROLINE GROUND2005-08-04
AMBU, INC.
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR2004-11-15
AMBU, INC.
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS2004-11-12
AMBU, INC.
AMBU DISPOSABLE ECG ELECTRODE2004-09-22
AMBU, INC.
AMBU DISPOSABLE PRESSURE MANOMETER2004-07-22
AMBU, INC.
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S2004-06-28
AMBU, INC.
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE2004-03-05
AMBU, INC.
AMBU GEL, HYDROGEL BURN DRESSING2001-05-25
AMBU, INC.
AMBU NEONATE SILICONE RESUSCITATOR2000-05-17
AMBU, INC.
AMBU HAND POWER SUCTION PUMP1999-10-25
AMBU, INC.
AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD1999-04-12
AMBU, INC.
AMBU TUBECHECK1998-07-17
AMBU, INC.
AMBU SPUR NEONATE1997-05-15
AMBU, INC.
AMBU PORTABLE SUCTION UNIT1995-05-05
AMBU, INC.
AMBU DISPOSABLE FACE MASK1993-06-22
AMBU, INC.
SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE1993-02-05
AMBU, INC.
AMBU SINGLE PATIENT USE PEEP VALVE1993-01-05
AMBU, INC.
AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO1992-09-16
AMBU, INC.
AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR1992-09-16
AMBU, INC.
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM1992-06-19
AMBU, INC.
SPUR ADULT WITH OPEN RESERVOIR SYSTEM1992-06-19
AMBU, INC.
AMBU SILICONE RESUSCITATOR INFANT/CHILD1991-10-07
AMBU, INC.
AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT1991-05-28
AMBU, INC.
AMBU MATIC AUTOMATIC RESUSCITATOR1991-05-28
AMBU, INC.
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT1990-07-16
AMBU, INC.
AMBU LIFE KEY AND AMBU RES-CUE KEY1990-06-08
AMBU, INC.
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)1988-09-14
AMBU, INC.
AMBU TWIN PUMP - (MANUAL SUCTION PUMP)1988-09-02
AMBU, INC.
AMBU RMT VALVE1987-12-30
AMBU, INC.
AMBU CPAP SYSTEM1985-04-15
AMBU, INC.
AMBU RUBEN CIRCLE ANESTHESIA SYSTEM1984-11-15
AMBU, INC.
MARK III RESUSCITATOR1984-02-10

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE Code65891AMBU INC.
CAGE Code65891AMBU INC.
S.A.M. Registration65891 [107260275]AMBU INC.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202009268428Shanghai ,China (Mainland) -> Norfolk, VirginiaANESTHETIC FACE MASK1432 CTN
202009255696Shanghai ,China (Mainland) -> Norfolk, VirginiaANESTHETIC FACE MASK1432 CTN
2020092453549Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaAMBU MEDICAL EQUIPMENT21 PKG
2020092314006Singapore,Singapore -> Long Beach, CaliforniaMEDICAL PRODUCTS1147 CTN
2020092289940Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaAMBU MEDICAL EQUIPMENT21 PKG
2020092166831Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaAMBU MEDICAL EQUIPMENT21 PKG
2020091815670Mundra,India -> Norfolk, VirginiaDISPOSABLE ECG ELECTRODES418 PKG
2020091715040Singapore,Singapore -> Long Beach, CaliforniaMEDICAL PRODUCTS1243 CTN
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