AccessGUDID - DEVICE: Christmas Tree Connectors

GUDID

Device Identifier (DI) Information

Brand Name: Christmas Tree Connectors - Non-Swivel
Version or Model: RES001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RES001
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530060008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Christmas Tree Connectors - Non-Swivel (10/pack)

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:	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?
38047	Nitrous oxide/oxygen quick-connect coupling, female	A female connecting device used to accept a male nitrous oxide/oxygen connector to connect two devices together to provide a continuous passageway for the delivery of a mixture of 50% nitrous oxide (N2O) and 50% oxygen (O2). It has safety features such as a specific mechanical mating pattern, colour coding and a dedicated tube diameter connection to prevent wrong connection and allow a user to rapidly connect and disconnect nitrous oxide/oxygen dependent devices. It can be designed as a diameter-indexed safety system (DISS) connector or a non-interchangeable screw-threaded (NIST) connector. This is not a nitrous oxide/oxygen terminal unit.	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: ba865173-cc84-4ac9-a66e-f20a5fb4e94a
Public Version Date: August 29, 2018
Public Version Number: 1
DI Record Publish Date: July 29, 2018