TEMPUR-PEDIC WHEELCHAIR PAD 20"X18"X3"

Basic Information

• Brand Name: TEMPUR-PEDIC WHEELCHAIR PAD 20"X18"X3"
• Primary DI: 00842430100413
• Version / Model: 69464
• Catalog Number: 69464
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-28
• Public Version: 4
• Public Version Date: 2021-09-02
• Public Version Status: Update
• Public Device Record Key: ba079b66-4500-48ee-96bf-eb7a9d880cbe

Device Description

Made with Tempur-Pedic® Medical materials.

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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	00842430100413	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 38 Degrees Celsius