BED CVR-AFFINITY-BCK-U SEC-AIR-CAL117-PU

Basic Information

• Brand Name: BED CVR-AFFINITY-BCK-U SEC-AIR-CAL117-PU
• Primary DI: 00840828178907
• Version / Model: SMC-AFFINITY-UFB-AIR-PU
• Catalog Number: 24788
• Company Name: CURBELL MEDICAL PRODUCTS, INC.
• Labeler DUNS: 796452311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-30
• Public Version: 1
• Public Version Date: 2020-04-07
• Public Version Status: New
• Public Device Record Key: bccd4878-a8d5-452e-8c52-fdd64cc1a92e

Device Description

BED CVR-AFFINITY-BCK-U SEC-AIR-CAL117-PU

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: No
• Has Lot/Batch Number: Yes
• 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
FMW	Cover, Mattress (Medical Purposes)	General Hospital	880.6190	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62365	Bed mattress/cover set	A collection of devices designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep, and which may help to promote therapeutic postures. It typically consists of a bed mattress, mattress overlay/cover and wedge-shaped cushion which are typically made of knitted polyester, polyurethane foam, buckwheat husk or combinations of materials. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840828178907	GS1

Customer Contacts

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