AccessGUDID - DEVICE: Invacare® HomeFill® Oxygen System (00841447100034)

GUDID

Device Identifier (DI) Information

Brand Name: Invacare® HomeFill® Oxygen System
Version or Model: IOH200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: IOH200
Company Name: INVACARE CORPORATION

Primary DI Number: 00841447100034
Issuing Agency: GS1
Commercial Distribution End Date: November 21, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 076916246 *Terms of Use

Device Description: No description.

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?
61605	Oxygen compressor, home-use	A mains electricity (AC-powered) electromechanical device intended to be used in conjunction with a stationary oxygen concentrator to pressurize and fill/refill ambulatory oxygen cylinders with medical oxygen (O2). It is operated by the patient in the home to facilitate mobile oxygen therapy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAW	Generator, Oxygen, Portable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between -20 and 150 Degrees Fahrenheit
Handling Environment Temperature: between -20 and 150 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a8255a5d-1ece-47aa-a3d7-94dfed0b9ef9
Public Version Date: September 20, 2023
Public Version Number: 7
DI Record Publish Date: September 14, 2015