Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003135857

FEI Number

3003135857

Entity Name

FLIGHT MEDICAL INNOVATIONS LTD.

City/State/Country

PETACH TIKVA Central, IL

Establishment Address

7 HATNUFA ST., PETACH TIKVA Central 4951025, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Flight Medical Innovations Ltd (Owner Number: 9046407)

Owner / Operator Contact Address

7 Hatnufa St., Petach Tikva, IL-NOTA 4951025, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111683

PMA Number

N/A

All Registered Proprietary Names

Nerport HT50 Test Lung Kit O2 Kit F60/VX Quick Release Kit F60 Quick Release Kit F60 Rail Mount Kit Roll Stand for use with ventilators Ventoux Ventilator 3 Section Arm with Ex FLIGHT60 FLIGHT60 F60 DL Ped Flow Sensor Kit F60 DL Flow Sensor Kit F60 DL Single Use PC F60 DL Single Use Ped PC F60 Ped DL Flow Sensor Kit RD F60 SL Ped SU PC RD F60 SL Single Use Ped PC F60 Ped. SL FS Kit RD F60 SL Flow Sensor Kit F60 SL Single Use PC F60 DL Ped Single Use PC RD F60 SL ped. Flow Sensor Kit Flight 60 In use Carrying Case HT50 Dual Pac Flight 60 Flight60

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2008-05-14
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2022-12-30
PCM	Portable Liquid Oxygen Unit Stand	Physical Medicine	Class 1	890.5050	2023-04-30
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2023-05-01
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2023-04-30
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2025-01-30
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2025-01-30
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2023-05-02
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2014-05-26
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2012-08-02
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2012-08-02
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2023-05-01
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2009-01-27
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2009-01-27
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2010-09-12
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2010-09-12
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2011-11-24
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2011-11-24

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Flight Medical Innovations Ltd

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

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3001104093	DRAEGERWERK AG & CO. KGAA	LUEBECK Schleswig-Holstein, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003135857. Last updated year: 2026. Please use registration number 3003135857 when referencing this establishment in official correspondence.