FDA.reportPublic FDA data

BE 148-6 Gauge Adapter

Primary DI
M996BE14860
Brand
BE 148-6 Gauge Adapter
Company
INSTRUMENTATION INDUSTRIES, INCORPORATED
Model
BE 148-6
Catalog number
BE 148-6
Device description
"The Instrumentation Industries, Inc. BE 148-6 Gauge Adapter has a 1/8"" tubing connection on one end and a 15 mm I.D./22 mm O.D. connection on the other end for remote inspiratory monitoring.The BE 148-1 is designed to work with III Vacuum/Pressure Gauges and NIF Meters.The adapter is made of polycarbonate."
Published
2016-07-29
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
BXRMeter, Airway Pressure (Inspiratory Force)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXRMeter, Airway Pressure (Inspiratory Force)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081693000NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERSInstrumentation Industries, Inc.2008-09-11BXR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M996BE14860PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Airway pressure monitor, non-poweredA mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-412-854-1133raqa@iiimedical.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M996SR75C0SR 75-C Swivel Barbed Tubing AdapterSR 75-C ClearSR 75-C2026-04-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10788942547001PortexICU MEDICAL, INC.BXR2016-10-11
10788942548008PortexICU MEDICAL, INC.BXR2016-10-11
10788942560604PortexICU MEDICAL, INC.BXR2016-10-11
10788942560659PortexICU MEDICAL, INC.BXR2016-10-11
00026072011287Allied Medical LLCAllied Medical, LLCBXR2016-09-16
00260720011285Allied Healthcare Products Inc.ALLIED HEALTHCARE PRODUCTS, INC.BXR2016-09-16
M996BE14810BE 148-1 Gauge AdapterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996BE14910BE 149-1 Gauge AdapterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NS120TRR0NS 120-TRR Negative Inspiratory Force (NIF) MeterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NS30PBR0NS 30-PBR Negative Inspiratory Force (NIF) MeterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NS30TRR0NS 30-TRR Negative Inspiratory Force (NIF) MeterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NS60PBR0NS 60-PBR Negative Inspiratory Force (NIF) MeterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NS60TBR0NS 60-TBR Negative Inspiratory Force (NIF) MeterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NS60TRR0NS 60-TRR Negative Inspiratory Force (NIF) MeterINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NSGC0NS-GC Gauge CoverINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
M996NSGS0NS-GS Gauge StandINSTRUMENTATION INDUSTRIES, INCORPORATEDBXR2016-07-29
10641043340004NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01
10641043340028NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01
10641043340035NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01
30641043340008NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01
10641043340011NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01
30641043340022NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01
30641043340039NIFometerMERCURY ENTERPRISES, INC.BXR2016-04-01