The BAG manual resuscitator and accessories
Laerdal Medical AS
LAERDAL MEDICAL CORP.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2425852 | 2425852 | LAERDAL MEDICAL CORP. | 1 | Y | 2026-01-01 | 167 Myers Corners Rd Wappingers Falls NY US 12590 |
| 9610483 | 3002807435 | LAERDAL MEDICAL A/S | 1 | N | 2026-01-01 | Tanke Svilandsgate 30 STAVANGER Rogaland NO 4007 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 18681 | 1691291673 | K993668 | LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 | BTA | 1999-12-20 |
| 18681 | 1514916278 | K981415 | 0-20 CM H20 PEEP VALVE | BYE | 1998-07-14 |
| 18681 | 1226227425 | K880450 | RESUSCI PATIENT FACE SHIELD | BTM | 1988-03-04 |
| 18681 | 1641464775 | K251631 | The BAG manual resuscitator and accessories | BTM | 2025-11-24 |
| 18681 | 1735199670 | K183348 | Reusable Silicone Cover CPRmeter 2 | LIX | 2018-12-17 |
| 18681 | 1741781286 | K173886 | CPRmeter 2 CPR Feedback Device | LIX | 2018-03-23 |
| 18681 | 1356004021 | K132172 | NEONATALIE RESUSCITATOR | BTM | 2015-01-15 |
| 18681 | 1536173028 | K120065 | PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES | JCX | 2012-04-03 |
| 18681 | 1969814752 | K003927 | Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 | BTM | 2001-06-26 |
| 18681 | 1726714718 | ||||
| 18681 | 1925639709 | ||||
| 18681 | 1315893227 | ||||
| 18681 | 1548735329 | ||||
| 18681 | 1900047644 | ||||
| 18681 | 2022973507 |
Product Codes Associated With Registrations#
PMN#
NeoBeat, NeoBeat Mini
Laerdal Medical AS
Reusable Silicone Cover CPRmeter 2
Laerdal Medical AS
CPRmeter 2 CPR Feedback Device
Laerdal Medical AS
Reusable Full Silicone Cover
LAERDAL MEDICAL AS
NEONATALIE RESUSCITATOR
LAERDAL MEDICAL A/S
CPRMETER CPR FEEDBACK DEVICE
LAERDAL MEDICAL A/S
LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050
LAERDAL MEDICAL A/S
RESUSCI INFLATE-A-SHIELD CPR BARRIER
LAERDAL MEDICAL CORP.
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20
LAERDAL MEDICAL A/S
TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
LAERDAL MEDICAL CORP.
TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
LAERDAL MEDICAL CORP.
HEARTSTART 911
LAERDAL MEDICAL CORP.
LSU 2000 PORTABLE SUCTION UNIT
LAERDAL MEDICAL CORP.
LAERDAL(TM) POCKET MASK, MODIFICATION
LAERDAL MEDICAL CORP.
HEARTSTART 3000
LAERDAL MEDICAL CORP.
RESUSCI PATIENT FACE SHIELD
LAERDAL MEDICAL CORP.
LAERDAL POCKET MASK
LAERDAL MEDICAL CORP.
LAERDAL SUCTION UNIT
LAERDAL MEDICAL CORP.
MODULAIDE EMERG. CARDIAC LIFE SUPP. KT
LAERDAL MEDICAL CORP.
GUDID#
The BAG™ Resuscitator - Pediatric model - Laerdal The BAG is a non-sterile single use selfinflatingmanual resuscitator. It may be used multipletimes on a single patient when kept free fromcontamination.
2026-03-30
The BAG™ Resuscitator - Adult model - Laerdal The BAG is a non-sterile single use selfinflatingmanual resuscitator. It may be used multipletimes on a single patient when kept free fromcontamination
2026-03-30
The BAG™ Resuscitator - Adult model - Laerdal The BAG is a non-sterile single use selfinflatingmanual resuscitator. It may be used multipletimes on a single patient when kept free fromcontamination
2026-03-30
The BAG™ Resuscitator - Pediatric model - Laerdal The BAG is a non-sterile single use selfinflatingmanual resuscitator. It may be used multipletimes on a single patient when kept free fromcontamination.
2026-03-30
The BAG™ Resuscitator - Newborn model - Laerdal The BAG is a non-sterile single use selfinflatingmanual resuscitator. It may be used multipletimes on a single patient when kept free fromcontamination.
2026-03-30
Laerdal Silicone Masks - Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
2026-01-29
Laerdal Silicone Masks - Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
2026-01-29
Laerdal Silicone Masks - Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
2026-01-29
Laerdal Silicone Masks - Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
2026-01-29
Laerdal Silicone Masks - Laerdal Silicone Masks (LSM) is a mask that can be connected to a resuscitator.
2026-01-29
The BAG Manometer - The BAG Manometer is a non-sterile single use accessory for displaying the airway pressure use with Laerdal The BAG resuscitator. It may be used for single-patient multiple use when kept free from contamination.
2026-01-14
The BAG PEEP Valve 5-20 cmH2O - The BAG PEEP Valve is a non-sterile single patient use accessory for maintaining positive end-expiratory pressure (PEEP) with Laerdal The BAG resuscitator. It may be used for single-patient multiple use when kept free from contamination.
2026-01-14
The BAG PEEP Valve 2-10 cmH2O - The BAG PEEP Valve is a non-sterile single patient use accessory for maintaining positive end-expiratory pressure (PEEP) with Laerdal The BAG resuscitator. It may be used for single-patient multiple use when kept free from contamination.
2026-01-14
The BAG Mask size 5 - The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a single patient when kept free from contamination.
2026-01-14
The BAG Mask size 4 - The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a single patient when kept free from contamination
2026-01-14
The BAG Mask size 3 - The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a single patient when kept free from contamination
2026-01-14
The BAG Mask size 2 - The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a single patient when kept free from contamination
2026-01-14
The BAG Mask size 1 - The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a single patient when kept free from contamination
2026-01-14
The BAG Manometer - The BAG Manometer is a non-sterile single use accessory for displaying the airway pressure use with Laerdal The BAG resuscitator. It may be used for single-patient multiple use when kept free from contamination.
2026-01-14
The BAG PEEP Valve 5-20 cmH2O - The BAG PEEP Valve is a non-sterile single patient use accessory for maintaining positive end-expiratory pressure (PEEP) with Laerdal The BAG resuscitator. It may be used for single-patient multiple use when kept free from contamination.
2026-01-14
The BAG PEEP Valve 2-10 cmH2O - The BAG PEEP Valve is a non-sterile single patient use accessory for maintaining positive end-expiratory pressure (PEEP) with Laerdal The BAG resuscitator. It may be used for single-patient multiple use when kept free from contamination.
2026-01-14
The BAG Mask size 5 - The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a single patient when kept free from contamination.
2026-01-14
The BAG Mask size 4 - The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a single patient when kept free from contamination
2026-01-14
The BAG Mask size 3 - The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a single patient when kept free from contamination
2026-01-14
The BAG Mask size 2 - The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a single patient when kept free from contamination
2026-01-14
The BAG Mask size 1 - The BAG Mask is a non-sterile single use face mask for use with Laerdal The BAG resuscitator. It may be used multiple times on a single patient when kept free from contamination
2026-01-14
BoundTree CPR Mask w/O2, one-way valve and filter - The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the rescuer and patient. The Pocket Mask with Oxygen Inlet can be connected to an external Oxygen source.
2015-10-20
Pocket Mask, HC Yellow (DE FR ES IT EN) - The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant, the mask may be turned 180° to achieve a better seal.
2025-08-27
Pocket Mask, SP Blue (DE FR ES IT EN) - The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant, the mask may be turned 180° to achieve a better seal.
2025-08-27
Pocket Mask, PB (DE FR ES IT EN) - The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant, the mask may be turned 180° to achieve a better seal.
2025-08-27
Pocket Mask, HC Yellow (DE FR ES IT EN) - The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant,the mask may be turned 180° to achieve a better seal.
2025-08-27
Pocket Mask, SP Blue (DE FR ES IT EN) - The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant,the mask may be turned 180° to achieve a better seal.
2025-08-27
Pocket Mask, PB (DE FR ES IT EN) - The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant,the mask may be turned 180° to achieve a better seal.
2025-08-27
Pocket Mask, HC Yellow (EN) - The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant,the mask may be turned 180° to achieve a better seal.
2025-08-25
Pocket Mask, SP Camo Private Label - The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant, the mask may be turned 180° to achieve a better seal.
2025-08-25
Pocket Mask, SP Black Private Label - The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant, the mask may be turned 180° to achieve a better seal.
2025-08-25
Pocket Mask, HC White Private Label - The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant, the mask may be turned 180° to achieve a better seal.
2025-08-25
Pocket Mask, SP Blue (EN) - The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant,the mask may be turned 180° to achieve a better seal.
2025-08-25
Pocket Mask, PB (EN) - The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant, the mask may be turned 180° to achieve a better seal.
2025-08-25
Pocket Mask, SP Camo Private Label - The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant,the mask may be turned 180° to achieve a better seal.
2025-08-25