REPLACEMENT COVER, URETHANE, 35"X83" (H80187)

Basic Information

• Brand Name: REPLACEMENT COVER, URETHANE, 35"X83" (H80187)
• Primary DI: 00840828162371
• Version / Model: MCD-3583
• Catalog Number: 9243
• Company Name: CURBELL MEDICAL PRODUCTS, INC.
• Labeler DUNS: 796452311
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 2
• Public Version Date: 2019-12-19
• Public Version Status: Update
• Public Device Record Key: 127b5bad-cf89-4f27-9f74-d82a8db5b8c8
• Distribution End Date: 2019-12-19

Device Description

REPLACEMENT COVER, URETHANE, 35"X83" (H80187)

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
58431	Probiotic bed mattress cover	A device made of soft textile materials shaped to fit over a bed mattress, to protect the mattress and prevent cross-contamination, that is treated/impregnated with probiotic bacteria intended to consume the allergen-containing faecal droppings of house dust mites (HDM) to reduce the risk of patient allergic reactions. The device can be laundered for cleaning. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840828162371	GS1

Customer Contacts

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