AccessGUDID - DEVICE: BE 105-101-40 Pressure Adapter with Silicone Connector (M996BE105101400)

GUDID

Device Identifier (DI) Information

Brand Name: BE 105-101-40 Pressure Adapter with Silicone Connector
Version or Model: BE 105-101-40
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BE 105-101-40
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996BE105101400
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

Device Description: The BE 105-101-40 Pressure Adapter with Connector: Dimensions - Barbed port fits 3/16" I.D. tubing x 15mm I.D./22mm O.D. x 22mm I/D (silicone connector end) . Barbed port is capped with a silicone rubber cap.

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):	No
Over the Counter (OTC):	Yes
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?
61621	Breathing circuit pressure detection port plug	A non-sterile device designed to seal the port of a breathing circuit pressure detection adaptor/connector (e.g., Y-piece) when the port is not needed for pressure monitoring. It is typically a small Luer cap made of plastic (e.g., polysulphone). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYX	Tubing, Pressure And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
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: 92b51c97-8c7e-43f2-9b9f-587a7875bbc6
Public Version Date: October 18, 2018
Public Version Number: 1
DI Record Publish Date: September 17, 2018