Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610483

FEI Number

3002807435

Entity Name

LAERDAL MEDICAL A/S

City/State/Country

STAVANGER Rogaland, NO

Establishment Address

Tanke Svilandsgate 30, STAVANGER Rogaland 4007, NO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LAERDAL MEDICAL A/S (Owner Number: 9038993)

Owner / Operator Contact Address

Tanke Svilandsgate 30, --, Stavanger, NO-11 4007, NO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173886

PMA Number

N/A

All Registered Proprietary Names

NeoNatalie Resuscitator NeoNatalie Complete Kit Newborn Mask Snap Design Laerdal Silicone Mask The BAG Mask The BAG PEEP Valve The BAG The BAG Manometer Laerdal Face Shield Laerdal Face Shield Key Ring Resusci Patient Face Shield American Red Cross Face Shield BaXstrap PadPack Alignment Pads The BAG II Disposable Resuscitator CPRmeter 2 Sta-Blocks SpeedBlocks CPRmeter 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2015-04-15
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2018-03-20
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2025-12-22
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2025-12-22
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2025-12-22
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-05-07
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2005-02-02
IQO	Device, Prosthesis Alignment	Physical Medicine	Class 1	890.3025	2005-02-02
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-02-25
LIX	Aid, Cardiopulmonary Resuscitation	Cardiovascular	Class 2	870.5210	2019-01-02
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2005-02-02
LIX	Aid, Cardiopulmonary Resuscitation	Cardiovascular	Class 2	870.5210	2018-03-27

Official Correspondent

No official correspondent registered.

US Agent Details

Carl Narvesen Business: Laerdal Medical Corporation Email: Carl.Narvesen@laerdal.com Phone: (845) 2455201

Related Public Records

Same Entity

LAERDAL MEDICAL A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3031563234	Laerdal Medical AS, Stavanger Manufacturing	Sandnes Rogaland, NO
3004993040	LAERDAL MEDICAL (SUZHOU) CO., LTD.	215009 SUZHOU JIANGSU PROVINCE, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812140	3M Company	BIRD MEAN AIRWAY PRESSURE MONITOR	1981-08-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.
Z-0043-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM. Packaged under the name of Evergreen, Hospitak, Kentron, McKesson and Mada.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610483. Last updated year: 2026. Please use registration number 9610483 when referencing this establishment in official correspondence.