FDA.reportPublic FDA data

BE 142

Primary DI
M996BE1420
Brand
BE 142
Company
INSTRUMENTATION INDUSTRIES, INCORPORATED
Model
BE 142
Device description
The reusable BE 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.
Published
2015-10-24
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
BYEAttachment, Breathing, Positive End Expiratory Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963347000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963347000REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142Instrumentation Industries, Inc.1997-03-19BYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M996BE1420PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
PEEP valve, reusableA non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Radiation Sterilization"", ""Ethylene Oxide"", ""High-level Disinfectant""]"

Contacts#

Phone, Email table
PhoneEmail
412-854-1133raqa@iiimedical.com

Regulatory Flags#

DUNS number
053146767
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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M996KC211D0KC 211-D 60 degree Angle Wye ConnectorKC 211-DKC 211-D2019-05-11
M996KC212D0KC 212-D 90 degree Angle Wye ConnectorKC 212-DKC 212-D2019-05-11
M996KC213D0KC 213-D 60 degree Angle Wye ConnectorKC 213-DKC 213-D2019-05-11
M996KC213D6KC 213-D 60 degree Angle Wye ConnectorKC 213-DKC 213-D2019-05-11
M996NC125850NC 12585 Nose ClipNC 12585NC 125852024-07-16
M996SH74BK0SH 74-BK Barbed Tubing AdapterSH 74-BK - BlackSH 74-BK2017-03-31
M996SH74BL0SH 74-BL Barbed Tubing AdapterSH 74-BL - BlueSH 74-BK2017-03-31
M996SH74C0SH 74-C Barbed Tubing AdapterSH 74-C - ClearSH 74-C2017-03-31
M996SH74G0SH 74-G Barbed Tubing AdapterSH 74-G - GreenSH 74-G2017-03-31
M996SH74W0SH 74-W Barbed Tubing AdapterSH 74-W - WhiteSH 74-W2017-03-31
M996SH74Y0SH 74-Y Barbed Tubing AdapterSH 74-Y - YellowSH 74-Y2017-03-31
M996SH75BK0SH 75-BK Barbed Tubing AdapterSH 75-BK - BlackSH 75-BK2017-03-31
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
M996BE1690BE 169 Oxygen Tank Wrench with Security CableBE 1692017-05-31
M996BE169W0BE 169-W Oxygen Tank WrenchBE 169-W2017-05-31

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