Span-America

Basic Information

• Brand Name: Span-America
• Primary DI: H9338410
• Version / Model: PressureGuard Custom Care Convertible
• Catalog Number: 8410
• Company Name: SPAN-AMERICA MEDICAL SYSTEMS, INC.
• Labeler DUNS: 073704413
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-13
• Public Version: 2
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: 71cca192-c8e7-4390-88f4-a9a8c1c07a10

Device Description

Alternating Pressure Mattress Control Unit

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
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	880.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36688	Alternating-pressure pump	An electrically-powered device that forces ambient air into the parallel chambers of an alternating-pressure bed mattress overlay or an alternating-pressure chair cushion, for the timed alternation of chamber inflation and thereby exchange of patient contact points. The pump, which may be programmable, ensures a regular exchange of the overlay/cushion pressure points for the patient.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	H9338410	HIBCC