AccessGUDID - DEVICE: The Harris Products Group (00850005066002)

GUDID

Device Identifier (DI) Information

Brand Name: The Harris Products Group
Version or Model: Regulator REG,3500-125-540
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3003500
Company Name: J. W. HARRIS CO., INC.

Primary DI Number: 00850005066002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004233490 *Terms of Use

Device Description: MATERIAL ADDED TO SYSTEM FOR TEST - NOT A HARRIS BRANDED MEDICAL REGULATOR, NO DI REQUIREMENT

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?
60944	Medical air cylinder regulator	A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical air cylinder to lower high, variable gas pressure (e.g., 50 - 250 bar) to a lower, constant working pressure (typically 3 - 5 bar). It can be a single- or dual-stage regulator, usually of a piston or diaphragm design. It includes a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may include associated devices, usually a manometer(s), to display the available gas reserve of the air cylinder and the working pressure.	Obsolete	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
No Device Sizes

Device Record Status

Public Device Record Key: 2266d1b1-cedc-4e32-928c-365e76e28e8e
Public Version Date: May 20, 2020
Public Version Number: 2
DI Record Publish Date: May 09, 2019