C-MATT

Basic Information

• Brand Name: C-MATT
• Primary DI: 00815073021995
• Version / Model: H10327
• Catalog Number: H10327
• Company Name: CASCO MANUFACTURING SOLUTIONS, INC.
• Labeler DUNS: 004253936
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-05
• Public Version: 1
• Public Version Date: 2019-04-15
• Public Version Status: New
• Public Device Record Key: e575dad1-3104-42f8-8f0a-d013be17b189

Device Description

Affinity Birthing Bed U / Straight Foam Seat and Back Cover Only

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
FMW	COVER, MATTRESS (MEDICAL PURPOSES)	General Hospital	880.6190	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37455	Waterproof bed mattress cover, reusable	A device made of soft, waterproof material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination, and prevent exposure to soiling, typically bedwetting or spills of other liquids. It 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	00815073021995	GS1