Identity
- Trade Name
- MADA MEDICAL PRODUCTS, INC. FDA UDI
- Generic Name
- Demand valve FDA UDI
- Device Name
- It is a demand valve with a hose without a mask. A non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device. FDA UDI
- Model / Reference
- 1534 FDA UDI
- Description
- It is a demand valve with a hose without a mask. A non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- 1534 FDA UDI
- Primary DI / UDI-DI
- 00815160020399 FDA UDI
- 510(k) Number
- K915564 FDA UDI
- FDA Product Code
- BTL FDA UDI
- GMDN Term
- Demand valve FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5925 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Demand valve
Mada Medical Products, Inc. by Mada Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Allied Medical LLC — Allied Medical LLC · Class II
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- Life Support Products — Allied Medical LLC · Class II
Cleared under the same submission
K915564 also covers:
- Allied Medical LLC — Allied Medical LLC
- Allied Medical LLC — Allied Medical LLC
- Allied Medical LLC — Allied Medical LLC
- Life Support Products — Allied Medical LLC
- Life Support Products — Allied Medical LLC
- Life Support Products — Allied Medical LLC
- Life Support Products — Allied Medical LLC
- Life Support Products — Allied Medical LLC
- Life Support Products — Allied Medical LLC
- Life Support Products — Allied Medical LLC
- Life Support Products — Allied Medical LLC
- Life Support Products — Allied Medical LLC
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
- Mada Medical Products, Inc.
Sources (1)
- FDA UDI 4d34e002-13ee-4f2d-9917-655ac4901f0e 36 fields · synced Jun 8, 2026