Identity
- Trade Name
- MADA MEDICAL PRODUCTS, INC. FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, reusable FDA UDI
- Device Name
- A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS). This is a reusable device. FDA UDI
- Model / Reference
- 1436 FDA UDI
- Description
- A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS). This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- 1436 FDA UDI
- Primary DI / UDI-DI
- 00815160021020 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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Implantable
No
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Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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Convenience Kit
No
FDA UDI
Combination Product
No
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HCT/P
No
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Premarket Exempt
Yes
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Lot / Batch Number
Yes
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Serial Number
Yes
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Expiration Date
No
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Manufacturing Date
Yes
FDA UDI
Category: Cardiopulmonary resuscitation mask, reusable
Mada Medical Products, Inc. by Mada Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary resuscitation mask, reusable.
- MICROTEK — Microtek Medical LLC · Class II
- OP - First aid series — Yiwu Ori-Power Medtech Co., Ltd. · Class I
- Pocket Mask O2, SP Black Private Label — Laerdal Medical Corp. · Class I
- Adsafe™ — American Diagnostic Corporation · Class I
- MICROTEK — Microtek Medical LLC · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Pocket Mask w/O2, SP (Black IE) — Laerdal Medical Corp. · Class II
- HEADSTAR — Headstar Medical Products Co., Ltd. · Class I
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
- Mada Medical Products, Inc.
Sources (1)
- FDA UDI b4b4f62f-4816-4cfe-be98-c42c0289a97b 35 fields · synced Jun 6, 2026