AccessGUDID - DEVICE: 2 CYL.CART (N2O REGULATOR) (00816711020585)

GUDID

Device Identifier (DI) Information

Brand Name: 2 CYL.CART (N2O REGULATOR)
Version or Model: 2100-N
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PARKER-HANNIFIN CORPORATION

Primary DI Number: 00816711020585
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004175550 *Terms of Use

Device Description: 2 CYL.CART (N2O REGULATOR) - This is an accessory only; not a medical device

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?
35086	Gas cylinder trolley	A dedicated cart designed to hold and secure one or more medical gas cylinders of compressed gas; but may be used for other types of gases, both during transport and static placement. The usual gases are [e.g., oxygen (O2), air, nitrous oxide (N2O) or helium (He)]. This trolley (cart) is used to prevent the cylinder(s) from falling both during transport and whilst the gas is being used. It is typically constructed of a metal framework [coated iron (Fe) or aluminium (Al)] and designed for standing upright on the floor when not in transport. It is configured to hold a certain size of gas cylinder(s) and will include a handle, a cylinder(s) securing device, and a pair of wheels.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZR	Mixer, Breathing Gases, Anesthesia Inhalation

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: db651e60-504a-452a-9ca0-d86844d95eba
Public Version Date: February 24, 2025
Public Version Number: 4
DI Record Publish Date: September 30, 2017