AccessGUDID - DEVICE: HOSE,O2,DISS FE/DISS MA 1 (00816711023401)

GUDID

Device Identifier (DI) Information

Brand Name: HOSE,O2,DISS FE/DISS MA 1
Version or Model: 80010-F/M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 80010-F/M
Company Name: PARKER-HANNIFIN CORPORATION

Primary DI Number: 00816711023401
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004175550 *Terms of Use

Device Description: HOSE,O2,DISS FE/DISS MA 1

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?
42039	Oxygen low pressure hose	A length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct compressed oxygen (O2) from an O2 terminal unit or O2 cylinder to a medical device that functions with O2 (e.g., ventilators, anaesthesia unit, analgesia unit, and other O2 dependent respiratory 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; some types may include an integrated mount. 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: a5c52179-7e47-4354-b98a-1f6ca963fa9b
Public Version Date: December 11, 2024
Public Version Number: 2
DI Record Publish Date: December 02, 2022