Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1218704

FEI Number

3003952420

Entity Name

BIO-MED DEVICES, INC.

City/State/Country

GUILFORD, CT, US

Establishment Address

61 SOUNDVIEW RD, GUILFORD, CT 06437, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIO-MED DEVICES, INC. (Owner Number: 1218704)

Owner / Operator Contact Address

61 SOUNDVIEW RD, --, Guilford, CT 06437, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K925982

PMA Number

N/A

All Registered Proprietary Names

M-1 PRESSURE MONITOR BIO-MED DEVICES BREATHING CIRCUIT MVP-10 VENTILATOR TV-100 Ventilator CROSSVENT-4+ CROSSVENT VENTILATOR CROSSVENT-2i+ CROSSVENT-3+ AIR-OXYGEN BLENDER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2007-11-30
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2002-09-11
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2007-11-30
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2018-07-24
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2007-11-30
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2007-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIO-MED DEVICES, INC.

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
K812140	3M Company	BIRD MEAN AIRWAY PRESSURE MONITOR	1981-08-20
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1218704. Last updated year: 2026. Please use registration number 1218704 when referencing this establishment in official correspondence.