AccessGUDID - DEVICE: Oxygen Tubing Swivel Connector Kit (00848530061890)

GUDID

Device Identifier (DI) Information

Brand Name: Oxygen Tubing Swivel Connector Kit
Version or Model: RES018KIT-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RES018KIT-1
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530061890
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: This kit contains: 1 RES018 Oxygen Tubing Connector - Swivel, 1 RES018ANS Oxygen Tubing Swivel Connector - Male to Female.

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
42988	Low-pressure tubing connector, reusable	A device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BZA	Connector, Airway (Extension)

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: 264de34b-7c86-4f11-a5d2-2880e06eeb8c
Public Version Date: August 31, 2018
Public Version Number: 1
DI Record Publish Date: July 31, 2018