Identity
- Trade Name
- Aquatic Solutions FDA UDI
- Generic Name
- Cardiopulmonary resuscitation kit, single-use FDA UDI
- Device Name
- Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Oxygen Port, two pieces alcohol pads and one pair Nitrile glove. CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. Infant CPR Mask without Oxygen Port is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It also functions as a barrier that will direct expired air from the patient away from the user. It is intended for over the counter use for infants with body weight up to 10kg (22 lbs). FDA UDI
- Model / Reference
- CP641000+CP641007+2A+NG FDA UDI
- Description
- Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Oxygen Port, two pieces alcohol pads and one pair Nitrile glove. CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. Infant CPR Mask without Oxygen Port is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It also functions as a barrier that will direct expired air from the patient away from the user. It is intended for over the counter use for infants with body weight up to 10kg (22 lbs). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946430401618 FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation kit, single-use FDA UDI
Classification
- 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
Yes
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: Cardiopulmonary resuscitation kit, single-use
Aquatic Solutions by Xiamen Compower Medical Tech. Co., Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary resuscitation kit, single-use.
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- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
- Ambu® SPUR® II Adult Resuscitator — Ambu A/S · Class II
- BROSELOW™ — Airlife, Inc. · Class II
- Ambu® SPUR® II Adult Resuscitator — Ambu A/S · Class II
- BROSELOW™ — Airlife, Inc. · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
- Ambu® SPUR® II Adult Resuscitator — Ambu A/S · Class II
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd
Sources (1)
- FDA UDI 4f16f38b-4cb0-4b96-a570-4040c8710335 33 fields · synced May 30, 2026