Identity
- Trade Name
- BE 148-5-2 Gauge Clamp FDA UDI
- Generic Name
- Airway pressure monitor, non-powered FDA UDI
- Device Name
- The BE 148-5-2 Gauge Clamp is an accessory to the NS Series Vacuum/Pressure Gauges. The BE 148-5-2 securely mounts Gauges with a rear 1/4" NPT thread to poles with 3/4" to 1-1/2" diameter. FDA UDI
- Model / Reference
- BE 148-5-2 FDA UDI
- Description
- The BE 148-5-2 Gauge Clamp is an accessory to the NS Series Vacuum/Pressure Gauges. The BE 148-5-2 securely mounts Gauges with a rear 1/4" NPT thread to poles with 3/4" to 1-1/2" diameter. FDA UDI
Identifiers
- Catalog Number
- BE 148-5-2 FDA UDI
- Primary DI / UDI-DI
- M996BE148520 FDA UDI
- 510(k) Number
- K081778 FDA UDI
- FDA Product Code
- CAP FDA UDI
- GMDN Term
- Airway pressure monitor, non-powered 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: Airway pressure monitor, non-powered
BE 148-5-2 Gauge Clamp 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 148-5-2.5 Gauge Clamp — INSTRUMENTATION INDUSTRIES, INCORPORATED
- BE 148-5-3.5 Gauge Clamp — INSTRUMENTATION INDUSTRIES, INCORPORATED
- Cuff Pressure Monitor Adapter — 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 220d3ae5-23ce-490a-a11d-9a3b486989fd 36 fields · synced Jun 8, 2026