Identity
- Trade Name
- Cuff Pressure Monitor Adapter FDA UDI
- Generic Name
- Artificial airway tube cuff pressure monitor FDA UDI
- Device Name
- The BE 148-4 Cuff Pressure Monitor Adapter attaches to NS Series gauges with a 1/4" NPT fitting to create a Cuff Pressure Monitor. During ventilation, the NS Series Cuff Pressure Monitors are devices used to periodically monitor endotracheal or tracheostomy tube balloon pressure to assure an adequate seal between the tube and the tracheal wall. These devices are intended to be used by or on the order of a physician. FDA UDI
- Model / Reference
- BE 148-4 FDA UDI
- Description
- The BE 148-4 Cuff Pressure Monitor Adapter attaches to NS Series gauges with a 1/4" NPT fitting to create a Cuff Pressure Monitor. During ventilation, the NS Series Cuff Pressure Monitors are devices used to periodically monitor endotracheal or tracheostomy tube balloon pressure to assure an adequate seal between the tube and the tracheal wall. These devices are intended to be used by or on the order of a physician. FDA UDI
Identifiers
- Catalog Number
- BE 148-4 FDA UDI
- Primary DI / UDI-DI
- M996BE14840 FDA UDI
- 510(k) Number
- K081778 FDA UDI
- FDA Product Code
- CAP FDA UDI
- GMDN Term
- Artificial airway tube cuff pressure monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2600 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: Artificial airway tube cuff pressure monitor
Cuff Pressure Monitor Adapter 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
K081778 also covers:
- BE 148-5-1 Gauge Clamp — INSTRUMENTATION INDUSTRIES, INCORPORATED
- BE 148-5-2 Gauge Clamp — INSTRUMENTATION INDUSTRIES, INCORPORATED
- BE 148-5-2.5 Gauge Clamp — INSTRUMENTATION INDUSTRIES, INCORPORATED
- BE 148-5-3.5 Gauge Clamp — INSTRUMENTATION INDUSTRIES, INCORPORATED
- Cuff Pressure Monitor Assembly — INSTRUMENTATION INDUSTRIES, INCORPORATED
- Cuff Pressure Monitor Assembly — INSTRUMENTATION INDUSTRIES, INCORPORATED
- NS 120-TRS Airway Pressure Monitor — INSTRUMENTATION INDUSTRIES, INCORPORATED
- NS 30-PBS Airway Pressure Monitor — INSTRUMENTATION INDUSTRIES, INCORPORATED
- NS 30-TRS Airway Pressure Monitor — INSTRUMENTATION INDUSTRIES, INCORPORATED
- NS 60-PBS Airway Pressure Monitor — INSTRUMENTATION INDUSTRIES, INCORPORATED
- NS 60-TBS Airway Pressure Monitor — INSTRUMENTATION INDUSTRIES, INCORPORATED
- NS 60-TRS Airway Pressure Monitor — INSTRUMENTATION INDUSTRIES, INCORPORATED
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 df25a320-ce18-43cb-ba56-40ce7ebc30b9 36 fields · synced May 30, 2026