AccessGUDID - DEVICE: Invacare® Platinum® Mobile Oxygen Concentrator 12V DC Power Cable (00841447103417)

GUDID

Device Identifier (DI) Information

Brand Name: Invacare® Platinum® Mobile Oxygen Concentrator 12V DC Power Cable
Version or Model: POC1-140
Commercial Distribution Status: In Commercial Distribution
Catalog Number: POC1-140
Company Name: INVACARE CORPORATION

Primary DI Number: 00841447103417
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076916246 *Terms of Use

Device Description: Invacare POC1-140 12V DC Power Cable Platinum Mobile O2 Concentrator

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?
31321	Mobile/portable oxygen concentrator	A mobile/portable mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, to a patient requiring oxygen therapy. It processes the air through an internal filtration system, e.g., a molecular sieve (zeolite granules or membranes), having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, filters, dual chambers, a reservoir and controls. The O2 concentration is variable depending on the flow rate utilized. It is used in a home, institution, or a vehicle and typically has internal batteries for transportable use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAW	Generator, oxygen, portable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160630	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2ffc1f9f-9df3-4c34-8fea-5417e0dfe8ca
Public Version Date: April 18, 2024
Public Version Number: 1
DI Record Publish Date: April 10, 2024