AccessGUDID - DEVICE: N2O Hose 2 ft DISS-DISS with 90 Angle Elbow (00816711024446)

GUDID

Device Identifier (DI) Information

Brand Name: N2O Hose 2 ft DISS-DISS with 90 Angle Elbow
Version or Model: 8582
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8582
Company Name: PARKER-HANNIFIN CORPORATION

Primary DI Number: 00816711024446
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004175550 *Terms of Use

Device Description: N2O Hose 2 ft DISS-DISS with 90 Angle Elbow

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?
37936	Nitrous oxide low pressure hose	A length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct compressed nitrous oxide (N2O) from an N2O terminal unit or N2O cylinder to a medical device that functions with N2O (e.g., ventilator, anaesthesia unit, analgesia unit, or other N2O dependent medical device). The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 5 bar), having been reduced by a regulator from a high pressure. The tubing is reinforced with, e.g., woven polyester or cotton and intended for use within a static clinical environment (e.g., intensive care). It is available in various lengths, including standard coil lengths. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYX	Tubing, Pressure And Accessories

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: 5680dbaf-3667-4c36-b13a-32ed3ded6d13
Public Version Date: April 15, 2024
Public Version Number: 1
DI Record Publish Date: April 05, 2024