O2 ADJUSTER 10 14x15x4"

Basic Information

• Brand Name: O2 ADJUSTER 10 14x15x4"
• Primary DI: 08717261040905
• Version / Model: OAD10/3538
• Company Name: Vicair B.V.
• Labeler DUNS: 416605657
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-14
• Public Version: 1
• Public Version Date: 2023-12-22
• Public Version Status: New
• Public Device Record Key: 6a815a1b-3be7-4cef-a24c-8f1b04b86d8a

Device Description

Wheelchair cushion

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IMP	CUSHION, WHEELCHAIR	Physical Medicine	890.3920	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11100	Wheelchair seat cushion	A padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08717261040905	GS1

Device Sizes

Type	Value	Unit	Text
Depth	15	Inch
Device Size Text, specify
Width	14	Inch