Identity
- Trade Name
- BE 30-142 FDA UDI
- Generic Name
- PEEP valve, reusable FDA UDI
- Device Name
- The reusable BE 30-142 is designed for use with ventilators, anesthesia machines, resuscitators, and other systems where PEEP or CPAP is required. A threshold-like resistance is applied after active exhalation. The PEEP valve prevents the exhalation pressure from dropping below a pre-determined value. PEEP ranges are adjustable from 3 to 20cm of water. Maximum PEEP can vary +/-10%. Objectives of PEEP therapy: 1) increase functional residual capacity by maintaining a positive pressure throughout the ventilatory cycle - improves gas distribution, 2) aid in the prevention of atelectasis via aveolar stinting, 3) decrease in the inspired oxygen fraction (FiO2) is an advantage, 4) help in the stabilization of flail chest condition, and 5) monitor tidal volume by connecting a spirometer to the outlet port. FDA UDI
- Model / Reference
- BE 30-142 FDA UDI
- Description
- The reusable BE 30-142 is designed for use with ventilators, anesthesia machines, resuscitators, and other systems where PEEP or CPAP is required. A threshold-like resistance is applied after active exhalation. The PEEP valve prevents the exhalation pressure from dropping below a pre-determined value. PEEP ranges are adjustable from 3 to 20cm of water. Maximum PEEP can vary +/-10%. Objectives of PEEP therapy: 1) increase functional residual capacity by maintaining a positive pressure throughout the ventilatory cycle - improves gas distribution, 2) aid in the prevention of atelectasis via aveolar stinting, 3) decrease in the inspired oxygen fraction (FiO2) is an advantage, 4) help in the stabilization of flail chest condition, and 5) monitor tidal volume by connecting a spirometer to the outlet port. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M996BE301420 FDA UDI
- 510(k) Number
- K963347 FDA UDI
- FDA Product Code
- BYE FDA UDI
- GMDN Term
- PEEP valve, reusable 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: PEEP valve, reusable
Be 30-142 by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K963347 also covers:
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
- Instrumentation Industries, Incorporated
Sources (1)
- FDA UDI a5b2e9e2-ba27-4fcb-b688-98f984724b23 35 fields · synced Jun 8, 2026