AccessGUDID - DEVICE: BE 117 Non-Rebreathing Tee Valve (M996BE1170)

GUDID

Device Identifier (DI) Information

Brand Name: BE 117 Non-Rebreathing Tee Valve
Version or Model: BE 117
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996BE1170
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35425	Non-rebreathing valve, reusable	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBP	Valve, Non-Rebreathing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973066	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization
Ethylene Oxide
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 30aa1d2c-37b1-4610-b64e-4bdf30a87390
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2015