Identity
- Trade Name
- Hyperinflation System FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Model / Reference
- 10-55858 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10641043558584 FDA UDI
- 510(k) Number
- K001714 FDA UDI
- FDA Product Code
- NHK FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
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
Category: Pulmonary resuscitator, manual, single-use
The Hyperinflation System is a non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. This single-use device is used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital.
Similar devices
Also classified as Pulmonary resuscitator, manual, single-use.
- Ventlab — Ventlab Corp. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
- VT Sure — Pulmodyne Inc. · Class II
- SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
- Ventlab — Ventlab Corp. · Class I
- Ventlab — Ventlab Corp. · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
Cleared under the same submission
K001714 also covers:
- Hyperinflation System — MERCURY ENTERPRISES, INC.
- Hyperinflation System — MERCURY ENTERPRISES, INC.
- Hyperinflation System — MERCURY ENTERPRISES, INC.
- Hyperinflation System — MERCURY ENTERPRISES, INC.
- Hyperinflation System — MERCURY ENTERPRISES, INC.
- Hyperinflation System — MERCURY ENTERPRISES, INC.
- Hyperinflation System — MERCURY ENTERPRISES, INC.
- Hyperinflation System — MERCURY ENTERPRISES, INC.
- Hyperinflation System — MERCURY ENTERPRISES, INC.
- Hyperinflation System — MERCURY ENTERPRISES, INC.
- Hyperinflation System — MERCURY ENTERPRISES, INC.
- NuFLO2 Hyperinflation System — MERCURY ENTERPRISES, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mercury Enterprises, Inc.
Sources (1)
- FDA UDI b21c3e96-49de-496e-af1d-b493d081db6b 34 fields · synced Jul 18, 2026