FDA.reportPublic FDA data

BE 117 Non-Rebreathing Tee Valve

Primary DI
M996BE1170
Brand
BE 117 Non-Rebreathing Tee Valve
Company
INSTRUMENTATION INDUSTRIES, INCORPORATED
Model
BE 117
Device description
The reusable BE 117 Non-Rebreathing ‘T’ is designed for use with a spontaneously breathing patient where “back flow” must be avoided. The ‘T’ is designed to prevent the flow of gas back toward the source and to ensure unilateral breathing.
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
CBPValve, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973066000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973066000NON-REBREATHING 'T' (BE 117)Instrumentation Industries, Inc.1998-02-03CBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M996BE1172PackageHIBCC10In Commercial Distribution
M996BE1170PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing valve, reusableA non-sterile device that is a one-way valve used to direct the flow of breathing gases and prevent the patient rebreathing the exhaled gases. It is typically used in a breathing system or between an oxygen mask and its reservoir bag. The device may be of various designs and will typically include unidirectional valves made of, e.g., silicone, rubber, metal, mica, sheets or discs that open and close for each inspiration/expiration. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""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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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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