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Sign in to claim this brandMERCURY ENTERPRISES, INC.
US
Last updated May 24, 2026
What MERCURY ENTERPRISES, INC. makes
Mercury Enterprises, Inc. manufactures single-use and reusable pulmonary resuscitators, including manual CPR bags like the CPR-2 Bag and NuFLO₂ Hyperinflation System, as well as disposable CPAP/BPAP nasal masks such as the Flow-Safe Disposable CPAP System. Their portfolio also includes single-use respiratory devices like the Mapleson anesthesia breathing circuit, Guedel oropharyngeal airways (including color-coded variants), anesthesia face masks, and oxygen administration tubing. Additionally, they produce respiratory oxygen sensors for monitoring oxygen levels in medical settings.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Mercury Enterprises, Inc. is based in the United States, where its products are regulated under U.S. medical device laws.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Mercury Enterprises, Inc. manufacture?
Mercury Enterprises, Inc. specializes in respiratory and resuscitation devices. Their portfolio includes single-use and reusable manual pulmonary resuscitators (like CPR bags), disposable CPAP/BPAP nasal masks, oropharyngeal airways (including color-coded Guedel Airways), anesthesia breathing circuits, face masks, oxygen administration tubing, and respiratory oxygen sensors. These devices are designed for critical care, anesthesia, and emergency resuscitation settings.
Where is Mercury Enterprises, Inc. based, and how does that affect its devices?
Mercury Enterprises, Inc. is based in the United States, where its devices are subject to U.S. medical device regulations. Since the company operates within the U.S., its products must comply with FDA requirements, including classification under FDA’s regulatory categories (Class I or Class II) and potential listing in the FDA’s Unique Device Identifier (UDI) database for traceability and regulatory tracking.
Which regulatory registries or databases list Mercury Enterprises, Inc.’s devices?
Mercury Enterprises, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to medical devices to improve tracking, reduce medical errors, and support regulatory oversight. Listing in this database helps ensure transparency and compliance with U.S. medical device regulations.
How are Mercury Enterprises, Inc.’s devices classified under FDA regulations?
Mercury Enterprises, Inc.’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls (e.g., manufacturing practices, labeling). Class II devices involve a higher level of risk and may require additional controls like special labeling or performance standards. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with.
Why do some of Mercury Enterprises, Inc.’s devices include terms like “single-use” or “reusable”?
The terms ‘single-use’ and ‘reusable’ describe the intended lifespan and sterilization requirements of the devices. Single-use devices (e.g., disposable CPAP masks or anesthesia breathing circuits) are designed for one-time use and disposal to ensure patient safety and hygiene. Reusable devices (e.g., some CPR bags) are engineered to withstand repeated use and sterilization, reducing waste but requiring strict cleaning and maintenance protocols to prevent contamination or degradation.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- mercurymed.com
- —
- —
- [email protected]
- Phone
- (727) 573-0088
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 032705659
Catalogue (411)
Page 7 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Guedel Airways | 10-81260 | FDA UDI | Class I | Active |
| Omni-Link/Flex-Link | 10-55361 | FDA UDI | Class I | Active |
| CPR-2 Bag | 10-56319 | FDA UDI | Class II | Active |
| CPR Bag | 10-55108 | FDA UDI | Class II | Active |
| CPR Bag | 10-54103 | FDA UDI | Class II | Active |
| CPR-2 Bag | 10-58208 | FDA UDI | Class II | Active |
| CPR-2 Bag | 10-56253 | FDA UDI | Class II | Active |
| Guedel Airways | 10-81250 | FDA UDI | Class I | Active |
| CPR Bag | 10-55500 | FDA UDI | Class II | Active |
| Mapleson Anesthesia Breathing Circuit | 10-80391 | FDA UDI | Class I | Active |
| CPR Bag Reusable | 10-50704 | FDA UDI | Class II | Active |
| Hyperinflation System | 10-55835 | FDA UDI | Class II | Active |
| Oxygen Sensor | 10-10301 | FDA UDI | Class II | Active |
| Berman Airways | 10-80000 | FDA UDI | Class I | Active |
| Flow-Safe Disposable CPAP System Tubing Kit | 10-55326 | FDA UDI | Class II | Active |
| Berman Airways (color coded) | 10-81570 | FDA UDI | Class I | Active |
| Head Harness Disposable | 10-57005 | FDA UDI | Class I | Unknown |
| Guedel Airways (color coded) | 10-81660 | FDA UDI | Class I | Active |
| Mapleson Anesthesia Breathing Circuit | 10-80378 | FDA UDI | Class I | Active |
| Flow-Safe Disposable CPAP System | 10-57035 | FDA UDI | Class II | Active |
| Flow-Safe Disposable CPAP System | 10-57013 | FDA UDI | Class II | Unknown |
| Guedel Airways (color coded) | 10-81690 | FDA UDI | Class I | Active |
| Resusa-Tee T-Piece Resuscitator | 10-51501 | FDA UDI | Class II | Active |
| Flow-Safe Disposable CPAP System | 10-57017 | FDA UDI | Class II | Unknown |
| CPR Bag | 10-58001 | FDA UDI | Class II | Active |
| CPR-2 Bag | 10-58212 | FDA UDI | Class II | Active |
| EZflow MAX | 10-32004 | FDA UDI | Class II | Active |
| CPR Bag Reusable | 10-50716 | FDA UDI | Class II | Active |
| CPR-2 Bag | 10-56050 | FDA UDI | Class II | Active |
| CPR Bag | 10-55107 | FDA UDI | Class II | Active |
| CPR Bag | 10-54216 | FDA UDI | Class II | Unknown |
| CPR Bag | 10-55709 | FDA UDI | Class II | Active |
| CPR Bag | 10-54220 | FDA UDI | Class II | Active |
| CPR-2 Bag | 10-56094 | FDA UDI | Class II | Active |
| CPR Bag | 10-55253 | FDA UDI | Class II | Active |
| Flow-Safe II EZ Disposable CPAP System | 10-57302 | FDA UDI | Class II | Active |
| Flow-Safe Disposable CPAP System | 10-57001 | FDA UDI | Class II | Active |
| Neo-Tee T-Piece Resuscitator | 10-50817 | FDA UDI | Class II | Unknown |
| CPR-2 Bag | 10-56063 | FDA UDI | Class II | Active |
| Guedel Airways (color coded) | 10-81670 | FDA UDI | Class I | Active |
| CPR Bag Reusable | 10-50724 | FDA UDI | Class II | Active |
| Head Harness Disposable | 10-57004 | FDA UDI | Class I | Active |
| CPR Bag Reusable | 10-50719 | FDA UDI | Class II | Active |
| Flow-Safe Disposable CPAP System | 10-57019 | FDA UDI | Class II | Active |
| Filter | 10-55375 | FDA UDI | Class II | Active |
| CPR Bag | 10-55068 | FDA UDI | Class II | Active |
| Mapleson Anesthesia Breathing Circuit | 10-80360 | FDA UDI | Class I | Active |
| Flow-Safe Disposable CPAP System | 10-57012 | FDA UDI | Class II | Active |
| Berman Airways (color coded) | 10-81540 | FDA UDI | Class I | Active |
| Oxygen Sensor | 10-10325 | FDA UDI | Class II | Active |
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