Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1024404

FEI Number

1024404

Entity Name

MERCURY MEDICAL

City/State/Country

CLEARWATER, FL, US

Establishment Address

11300 49th St N, CLEARWATER, FL 33762, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

MERCURY ENTERPRISES, INC. (Owner Number: 1024404)

Owner / Operator Contact Address

11300 49TH ST. NORTH, --, Clearwater, FL 33762, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STATCO2 (MINI) Hand Pump Assembly RESISTEX MASK, OXYGEN, NON-REBREATHING HYPERINFLATION BAG SYSTEM FACE CRADLE AIRWAYS (MULTIPLE) CPR BAG (MUTIPLE) FLOW-SAFE (CPAP) ANESTHESIA CIRCUIT (MAPLESON) EZFLOW MAX CONTINUOUS NEBULIZER NEO-TEE (T-PIECE RESUSCITATOR) T-PIECE CIRCUIT gas sampling lines DISPOSEAL TOOTH PROTECTOR PEEP VALVE RESUSA-TEE OC-Flex Flexible IntraOral Cannula Tubes - Gastrointestinal and Accessories CPR BAG (REUSABLE) NOSE CLIP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2007-11-15
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2023-04-18
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2007-11-15
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2003-06-20
NHK	Resuscitator, Manual, Non Self-Inflating	Anesthesiology	Class 2	868.5905	2007-11-15
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2004-10-15
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	1977-12-30
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-05-19
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2009-09-10
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	1977-12-30
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2016-03-07
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2010-05-14
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-03-10
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	1977-12-30
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2007-02-07
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2008-06-25
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2016-03-07
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-03-10
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2026-01-15
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2009-05-13
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	1995-01-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MERCURY ENTERPRISES, 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
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2025	Mercury Enterprises, Inc. dba Mercury Medical	2	Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3006307105	MedDev Manufacturing Sdn Bhd	Klang Selangor, MY
3038913749	INVENTEUR, LLC	Saint Petersburg, FL, US
3010427901	CMI Health, Inc.	Alpharetta, GA, US
3016678045	Schneider ASR B.V.	Rotterdam-Albrandswaard Zuid-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1024404. Last updated year: 2026. Please use registration number 1024404 when referencing this establishment in official correspondence.