The BAG manual resuscitator and accessories
Laerdal Medical AS
LAERDAL MEDICAL A/S
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 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
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20
LAERDAL MEDICAL A/S
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