Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2024500

FEI Number

2024500

Entity Name

COVIDIEN

City/State/Country

CARLSBAD, CA, US

Establishment Address

2101 Faraday Avenue, CARLSBAD, CA 92008, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Covidien llc (Owner Number: 1282497)

Owner / Operator Contact Address

15 HAMPSHIRE STREET, --, Mansfield, MA 02048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K883809

PMA Number

N/A

All Registered Proprietary Names

840 Vent with VV+ Renaissance 11 Spirometry System Clinivision DC compressor Ventilator Puritan Bennett 840 Series Ventilator System Ventilator Ventilator Breeze Sleepgear with Dreamseal Spirometer Compressor Ventilator HT70 SonarMed AirWave Airway Monitoring System Puritan Bennett 980 Series Ventilator System Ventilator U-MID VENTILATOR CIRCUITS Ventilator PMR-2 Puritan Manual Resuscitator Nebulizer Humidifier-Cascade II Humidifier Humidifier Ventilator Pyramesh INDGO Manual Resuscitator Ventilator Ventilator

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	2008-02-26
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2008-02-26
NSX	N/A	N/A	Class N/A	N/A	2011-04-14
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2015-01-07
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2015-04-28
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2016-04-11
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2015-04-28
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2015-04-28
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2008-02-26
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2015-04-28
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2015-04-28
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2015-04-28
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2015-02-26
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2015-02-26
OQU	Airway Monitoring System	Anesthesiology	Class 2	868.5730	2025-03-14
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-12-02
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2015-04-28
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2015-04-28
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	1991-12-23
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2016-03-09
MOD	Accessory To Continuous Ventilator (Respirator)	Anesthesiology	Class 2	868.5895	2015-04-28
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-02-28
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2015-04-28
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-02-28
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2015-07-02
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2015-07-02
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2015-05-13
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2008-02-26
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-02-28
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2015-04-28
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2015-04-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Covidien llc

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8020889	Mallinckrodt Medical	ATHLONE Westmeath, IE
3006451981	Covidien Medical Products (Shanghai) Manufacturing LLC	Shanghai, CN
8044004	ORIDION MEDICAL 1987 LTD.	JERUSALEM, IL
1282497	Covidien LLC	MANSFIELD, MA, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX

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
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2024500. Last updated year: 2026. Please use registration number 2024500 when referencing this establishment in official correspondence.