AccessGUDID - DEVICE: BPR Medical (05060274502858)

GUDID

Device Identifier (DI) Information

Brand Name: BPR Medical
Version or Model: Firesafe Nozzle - DISS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 827-0030
Company Name: BPR MEDICAL LIMITED

Primary DI Number: 05060274502858
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 236040130 *Terms of Use

Device Description: Firesafe Nozzle - DISS. The intended medical purpose is to act as part of a conduit assembly through which oxygen is delivered to patients during normobaric oxygen therapy. A further non-medical purpose is to extinguish a fire in oxygen therapy tubing and isolate the oxygen supply. The non-medical purpose is further described in the technical description below.

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):	Yes
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?
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
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated

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
Storage Environment Temperature: between -25 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b45db06a-b0f7-4565-b568-d62d7e3048c6
Public Version Date: June 15, 2023
Public Version Number: 1
DI Record Publish Date: June 07, 2023