Identity
- Trade Name
- GaleMed FDA UDI
- Generic Name
- PEEP valve, single-use FDA UDI
- Device Name
- Disposable Adjustable PEEP Valve 5-20cmH2O FDA UDI
- Model / Reference
- 2429-01 FDA UDI
- Description
- Disposable Adjustable PEEP Valve 5-20cmH2O FDA UDI
Identifiers
- Primary DI / UDI-DI
- 24710810082911 FDA UDI
- 510(k) Number
- K133957 FDA UDI
- FDA Product Code
- BYE FDA UDI
- GMDN Term
- PEEP valve, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5965 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: PEEP valve, single-use
GaleMed by GaleMed Xiamen Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as PEEP valve, single-use.
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- O2-CPAP — Pulmodyne Inc. · Class II
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- PEEP VALVE 15cmH2O;STRAIGHT CONNECTORS 30m, 22m — BESMED HEALTH BUSINESS CORP. · 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- GaleMed Xiamen Co., Ltd.
Sources (1)
- FDA UDI bdd57339-409b-4d60-b6b6-5702e556d9e1 35 fields · synced May 31, 2026