Identity
- Trade Name
- Konmed FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- KM-101 is a quick, inexpensive, easy to use resuscitation sheet with a one-way valve meant to provide a safe barrier between you and your patient. This CPR mask prevents your mouth, nose and face from coming into direct contact with the other person and is designed to stay securely in place during the procedure. FDA UDI
- Model / Reference
- CPR Mask Keyring Mode:KM-101 FDA UDI
- Description
- KM-101 is a quick, inexpensive, easy to use resuscitation sheet with a one-way valve meant to provide a safe barrier between you and your patient. This CPR mask prevents your mouth, nose and face from coming into direct contact with the other person and is designed to stay securely in place during the procedure. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970935830284 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 b7220db4-101f-479a-ab3d-2fca0434bf9d 33 fields · synced May 30, 2026