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Pocket BVM ® Cyclone
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref PBVM NAR (003NAR)Model Pocket BVM™ Manual Resuscitator
Identity
- Trade Name
- Pocket BVM ® Cyclone EUDAMEDFDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- Pocket BVM™ Manual Resuscitator EUDAMED"Pocket BVM is a manual emergency ventilator whose purpose is to manually apply positive pressure to a patient’s airways to support ventilation and oxygenation. The modified Pocket BVM incorporates bags and valve assemblies and is intended to provide emergency respiratory support to a patient through a tube inserted into the patient's airway or a face mask. The Pocket BVM device continues to maintain the functionality of existing devices and also has the advantage of small external dimensions (when packed) and light weight. It can be unpacked and made operational in seconds. " FDA UDI
- Model / Reference
- Pocket BVM™ Manual Resuscitator EUDAMEDPBVM NAR (003NAR) EUDAMEDPocket BVM ® cyclone FDA UDI
- Description
- "Pocket BVM is a manual emergency ventilator whose purpose is to manually apply positive pressure to a patient’s airways to support ventilation and oxygenation. The modified Pocket BVM incorporates bags and valve assemblies and is intended to provide emergency respiratory support to a patient through a tube inserted into the patient's airway or a face mask. The Pocket BVM device continues to maintain the functionality of existing devices and also has the advantage of small external dimensions (when packed) and light weight. It can be unpacked and made operational in seconds. " FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016824063 EUDAMEDFDA UDI
- Basic UDI-DI
- 729001682400BB EUDAMED
- Direct Marketing DI
- 07290016824063 EUDAMED
- FDA Product Code
- BTM FDA UDI
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
- GMDN Term
- Pulmonary resuscitator, manual, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulmonary resuscitator, manual, single-use
Pocket BVM ® Cyclone by Micro BVM Systems Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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
Manufacturer's product page: Pocket BVM
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093081 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 729001682400BB | Class I | Active |
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Manufacturer
- Manufacturer
- Micro BVM Systems Ltd
- EUDAMED SRN
- IL-MF-000004417
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 068a4171-b207-4e31-8c3a-e740b9456e14 61 fields · synced Jun 19, 2026
- FDA UDI 805ae225-4720-45fd-8bb5-6525acc9a082 34 fields · synced May 30, 2026
- FDA 510(k) K093081 1 fields · synced May 18, 2026