AccessGUDID - DEVICE: Protekt Regulator (05060488573187)

GUDID

Device Identifier (DI) Information

Brand Name: Protekt Regulator
Version or Model: PMREG04D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PMREG04D
Company Name: PROACTIVE MEDICAL PRODUCTS, LLC

Primary DI Number: 05060488573187
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078582655 *Terms of Use

Device Description: Oxygen Regulator, Pediatric, 0-4 LPM Full Size, CGA 540, Diss Outlet

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?
44472	Oxygen therapy conserving regulator	A device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cylinder, and is used to regulate the high pressure of the supply to a safe working pressure which is delivered to the patient requiring oxygen therapy and ensuring that the prescribed (set/dialed) dosage of O2 is maintained at an accurate level. It acts both as a pressure reduction device and an O2 saving device. Commonly known as an oxygen conserving regulator it may be designed to provide a bolus of O2 to the patient by metering the gas over the normal inspiration/expiration phases, thus conserving it.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAN	Regulator, Pressure, Gas Cylinder

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
Length: 6 Inch
Width: 2 Inch
Height: 2 Inch

Device Record Status

Public Device Record Key: 0f25fb27-6aad-422c-bb2a-86a3bd38f851
Public Version Date: October 25, 2022
Public Version Number: 2
DI Record Publish Date: October 13, 2022