AccessGUDID - DEVICE: Firesafe Connector Kit (00848530062125)

GUDID

Device Identifier (DI) Information

Brand Name: Firesafe Connector Kit
Version or Model: RES010KIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RES010KIT
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530062125
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: 2 RES010 Firesafe Bidirectional Thermal Shut-Off Cannula Valves, 1 RES010TC Firesafe Tubing Connector.

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?
60391	Oxygen tubing fire safety valve	A safety device intended to be integrated into oxygen delivery tubing to automatically stop the flow of oxygen and isolate the oxygen supply in the event of a fire. It typically consists of a small two-way tubing connector containing a thermal fuse. This is a single-patient, reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: 3c06b7c3-9468-4ffa-9e3e-b9dc7c3f0582
Public Version Date: September 09, 2020
Public Version Number: 2
DI Record Publish Date: July 31, 2018