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Manual Jet Ventilator

FDA UDI

Class II (US FDA UDI)

by Instrumentation Industries, Incorporated

Identity

Trade Name
Manual Jet Ventilator FDA UDI
Generic Name
Manual jet ventilation device FDA UDI
Device Name
The BE 183-SU-12 Manual Jet Ventilator is designed to provide trans-tracheal ventilation in specific emergency situations of upper airway obstructions. This system is used in conjunction with a trans-tracheal catheter, or cricothyrotomy needle, which is inserted through the cricothyroid membrane. Ventilation is accomplished by the manual, intermittent jetting of oxygen through the catheter for subsequent lung inflation. FDA UDI
Model / Reference
BE 183-SU-12 FDA UDI
Description
The BE 183-SU-12 Manual Jet Ventilator is designed to provide trans-tracheal ventilation in specific emergency situations of upper airway obstructions. This system is used in conjunction with a trans-tracheal catheter, or cricothyrotomy needle, which is inserted through the cricothyroid membrane. Ventilation is accomplished by the manual, intermittent jetting of oxygen through the catheter for subsequent lung inflation. FDA UDI

Identifiers

Catalog Number
BE 183-SU-12 FDA UDI
Primary DI / UDI-DI
M996BE183SU120 FDA UDI
510(k) Number
K991785 FDA UDI
FDA Product Code
BTL FDA UDI
GMDN Term
Manual jet ventilation device 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Manual jet ventilation device

Manual Jet Ventilator by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual jet ventilation device.

Cleared under the same submission

K991785 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Instrumentation Industries, Incorporated

Sources (1)

  • FDA UDI d65331ba-85f1-42a4-bd73-f402f956cc66 36 fields · synced Jun 1, 2026