FDA Registration
Active
🇺🇸 United States
MERCURY MEDICAL
Reg #: 1024404
·
FEI: 1024404
·
Expires 2026
Products
21
Proprietary Names
31
Establishment Types
3
Classifications
21
Registration Details
- Registration Name
- MERCURY MEDICAL
- Registration Number
- 1024404
- FEI Number
- 1024404
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 11300 49th St N
- City
- CLEARWATER
- State
- FL
- ZIP
- 33762
- Country
- US
Regulatory Submissions
- 510(k) Number
- K031411
Owner / Operator
- Firm Name
- MERCURY ENTERPRISES, INC.
- Operator Number
- 1024404
- Address
- 11300 49TH ST. NORTH, --
- City
- Clearwater
- State
- FL
- Postal Code
- 33762
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2007-11-15 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2023-04-18 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2007-11-15 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2003-06-20 |
| Resuscitator, Manual, Non Self-Inflating | NHK | Class 2 | Anesthesiology | No | 2007-11-15 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2004-10-15 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 1977-12-30 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2008-05-19 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2009-09-10 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 1977-12-30 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2016-03-07 |
| Ventilator, Emergency, Powered (Resuscitator) | BTL | Class 2 | Anesthesiology | No | 2010-05-14 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 1977-12-30 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2007-02-07 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 1995-01-05 |
| Meter, Airway Pressure (Inspiratory Force) | BXR | Class 2 | Anesthesiology | No | 2007-11-15 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 1995-01-05 |
| Percussor, Powered-Electric | BYI | Class 2 | Anesthesiology | No | 2015-02-12 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 1997-01-13 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2007-11-15 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 1977-12-30 |
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
NIFOMETER (NEGATIVE INSPIRATORY FORCE)
STATCO2 (ADULT)
EZFLOW CONTINUOUS NEBULIZER
CLEAR ANATOMICAL FACE MASK
SHURCLEAR
STATCO2 (NEO)
AIRWAY PRESSURE MANOMETER
EXHALATION FILTER (CPR)
OXYGEN TUBING (MULTIPLE)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device