Hyperinflation Bag System, Model 83-900-0149
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Hyperinflation EUDAMEDHyperinflation System FDA UDINuFLO2 Hyperinflation System FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- Hyperinflation System EUDAMED
- Model / Reference
- 10-55833 EUDAMEDFDA UDI10-55843 EUDAMEDFDA UDI10-55827 EUDAMEDFDA UDI10-55838 EUDAMEDFDA UDI10-56849 EUDAMEDFDA UDI10-55818 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 10641043558331 EUDAMEDFDA UDI10641043558430 EUDAMEDFDA UDI10641043558270 EUDAMEDFDA UDI10641043558386 EUDAMEDFDA UDI10641043568491 EUDAMEDFDA UDI10641043558188 EUDAMEDFDA UDI
- Basic UDI-DI
- 0641043HYNU EUDAMED
- 510(k) Number
- FDA Product Code
- NHK FDA 510(k)FDA UDI
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
- GMDN Term
- Pulmonary resuscitator, manual, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
The Hyperinflation Bag System, Model 83-900-0149, is a manual, non-self-inflating resuscitator designed for use in anesthesiology. Classified as a Class II device, it is intended for manual ventilation support during medical procedures requiring controlled airway management.
This system is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance and EU MDR compliance. It is regulated under the U.S. regulation number 868.5905 and is registered under multiple FEI numbers. Storage and handling must follow manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What is the primary clinical use for the Mercury Medical Hyperinflation Bag System, Model 83-900-0149?
This device is specifically designed for manual ventilation support during medical procedures that require controlled airway management, particularly in anesthesiology settings. It is intended to assist with breathing support when a patient’s natural respiratory function is insufficient or absent.
Is the Hyperinflation Bag System reusable or intended for single-use, and how does this affect its sterility?
The system is explicitly intended for single-use only and is supplied sterile to ensure patient safety. Reuse is not recommended, as it could compromise sterility and functionality, potentially leading to contamination or device failure during critical procedures.
What storage and handling precautions should be taken to maintain the device’s integrity?
To preserve sterility and functionality, storage and handling must strictly follow the manufacturer’s guidelines. This likely includes keeping the device in its original packaging until use, avoiding exposure to moisture or contamination, and storing it in a clean, dry environment away from direct sunlight or extreme temperatures.
How is this device regulated, and what does that mean for its use in clinical settings?
The Hyperinflation Bag System is classified as a Class II medical device and has received FDA 510(k) clearance under the U.S. regulation number 868.5905, as well as EU MDR compliance. This means it has undergone rigorous review by regulatory authorities to ensure safety and performance, allowing its use in clinical settings where controlled ventilation is required, such as in operating rooms or emergency care.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Mercury (planet) - Wikipedia, Mercury - Science@NASA
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K001714 | Class II | Active |
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Manufacturer
- Manufacturer
- Mercury Medical
Sources (13)
- FDA 510(k) K001714 24 fields · synced Sep 18, 2026
- FDA UDI e7147cd4-b2ba-4af8-992f-701cc44fd319 34 fields · synced May 22, 2026
- FDA UDI 6fab1f6d-ac0e-4e69-a23e-acd9d8f32426 34 fields · synced May 30, 2026
- FDA UDI e6d9c035-c52d-40c7-8445-d3535e62d128 34 fields · synced May 30, 2026
- FDA UDI 61a32b92-513c-4b13-bb04-beba5d829ec0 34 fields · synced May 30, 2026
- FDA UDI 2612281d-860e-4c14-9818-d3d42ea93839 34 fields · synced May 30, 2026
- FDA UDI 68636a9d-19e5-481d-8504-3132e925a05f 34 fields · synced May 30, 2026
- EUDAMED e51d750f-379c-496b-b9db-d7e758d3cbac 61 fields · synced Jun 20, 2026
- EUDAMED 0835d6ec-6a88-406c-89bf-b5a7e3f5f94f 61 fields · synced Jul 9, 2026
- EUDAMED 803d93b7-1c31-4728-a457-a2d8c63db2ea 61 fields · synced Jul 12, 2026
- EUDAMED 8cd35574-0576-4404-a9ae-45de714b669a 61 fields · synced Jul 19, 2026
- EUDAMED 8c372085-9aa6-4de4-a7ec-2ab0846b78e8 61 fields · synced Jul 20, 2026
- EUDAMED 1785707e-b06f-452e-afe4-3cc5acccd457 61 fields · synced Jul 29, 2026