Identity
- Trade Name
- Compower FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- The inteneded use for Child Disposable Manual Resuscitator: Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:Infant: greater than 5 kg and less than or equal to 10 kg; Pediatric: greater than 10 kg and less than or equal to 40 kg; Adult: greater than 40 kg. It is for child population. It is disposable. FDA UDI
- Model / Reference
- NPVC-002/RTMA FDA UDI
- Description
- The inteneded use for Child Disposable Manual Resuscitator: Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:Infant: greater than 5 kg and less than or equal to 10 kg; Pediatric: greater than 10 kg and less than or equal to 40 kg; Adult: greater than 40 kg. It is for child population. It is disposable. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946430410856 FDA UDI
- 510(k) Number
- K210288 FDA UDI
- FDA Product Code
- BTM FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Category: Pulmonary resuscitator, manual, single-use
Compower by Xiamen Compower Medical Tech. Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — 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
Cleared under the same submission
K210288 also covers:
- Med-Tech Resource — MED-TECH RESOURCE, LLC
- Med-Tech Resource — MED-TECH RESOURCE, LLC
- Med-Tech Resource — MED-TECH RESOURCE, LLC
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- EMI — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- EMI — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Lightning X — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
- Lightning X — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
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
- Xiamen Compower Medical Tech. Co., Ltd
Sources (1)
- FDA UDI 5bf655e3-72a1-47bb-9a6e-e5dd30478338 34 fields · synced May 30, 2026