Identity
- Trade Name
- Konmed FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- This CPR mask is designed for mouth to mask ventilation of a non-breathing adult, child, or infant. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training. FDA UDI
- Model / Reference
- CPR Pocket Mask Model:KM-102 FDA UDI
- Description
- This CPR mask is designed for mouth to mask ventilation of a non-breathing adult, child, or infant. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970935830345 FDA UDI
- FDA Product Code
- BYP FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5620 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiopulmonary resuscitation mask, single-use
Konmed by Shenzhen Konmed Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Konmed Technology Co., Ltd.
Sources (1)
- FDA UDI 9350c367-c553-4a80-be5d-4ecc8dd4adb2 33 fields · synced May 30, 2026