AccessGUDID - DEVICE: Oxygen Connector (00848530096861)

GUDID

Device Identifier (DI) Information

Brand Name: Oxygen Connector
Version or Model: RES001-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530096861
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Xmas Tree Connector - 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:	Yes
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: cde01193-6d0c-40b9-ac52-0d82ee937727
Public Version Date: April 23, 2025
Public Version Number: 1
DI Record Publish Date: April 15, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8775786738
Email: customerservice@sunsethcs.com

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