Cuff Pressure Monitor Adapter

Primary DI
M996BE14840
Brand
Cuff Pressure Monitor Adapter
Company
INSTRUMENTATION INDUSTRIES, INCORPORATED
Model
BE 148-4
Catalog number
BE 148-4
Device 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."
Published
2016-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081778000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081778000NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORSInstrumentation Industries, Inc.2008-09-12CAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M996BE14840PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Artificial airway tube cuff pressure monitorA mains electricity (AC-powered) device intended to intermittently or continuously measure the internal pressure in the cuff of an endotracheal (ET)/endobronchial/tracheostomy tube when this has been situated into the tracheal passage. Too high a cuff pressure and/or combined long periods of use can be damaging for the pressure site on the tracheal wall. It will provide and display a continuous monitoring of the situation which the anaesthetist can observe. Some types may also include the ability to inflate the cuff and regulate the pressure therein.

Contacts#

Phone, Email table
PhoneEmail
800-633-8577raqa@iiimedical.com

Regulatory Flags#

DUNS number
053146767
Device count
1
Lot or batch
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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M996SH75BL0SH 75-BL Barbed Tubing AdapterSH 75-BL - BlueSH 75-BL2017-03-31
M996SH75C0SH 75-C Barbed Tubing AdapterSH 75-C - ClearSH 75-C2017-03-31
M996SH75G0SH 75-G Barbed Tubing AdapterSH 75-G - GreenSH 75-G2017-03-31
M996SH75W0SH 75-W Barbed Tubing AdapterSH 75-W - WhiteSH 75-W2017-03-31
M996SH75Y0SH 75-Y Barbed Tubing AdapterSH 75-Y - YellowSH 75-Y2017-03-31
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