AccessGUDID - DEVICE: SH 75-BL Barbed Tubing Adapter (M996SH75BL0)

GUDID

Device Identifier (DI) Information

Brand Name: SH 75-BL Barbed Tubing Adapter
Version or Model: SH 75-BL - Blue
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SH 75-BL
Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED

Primary DI Number: M996SH75BL0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053146767 *Terms of Use

Device Description: The SH 75-BL Barbed Tubing ("Christmas Tree" Style) Adapter fits outlets with DISS 1240 9/16-18 threads. This is a Single Patient Use adapter; Not reusable.

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:	Yes
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?
60856	Oxygen administration kit	A collection of devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use 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: No

Sterilization Method [?]
No Sterilization Methods Found

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: fc947928-62e4-4bc3-a90f-d78cf099ad83
Public Version Date: February 05, 2024
Public Version Number: 3
DI Record Publish Date: March 31, 2017