DMI

Basic Information

• Brand Name: DMI
• Primary DI: 00041298080800
• Version / Model: 555-8080-0121
• Company Name: D-M-S HOLDINGS, INC.
• Labeler DUNS: 062028220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-08
• Public Version: 1
• Public Version Date: 2023-09-18
• Public Version Status: New
• Public Device Record Key: d7424ed6-eb21-4a61-92e5-3ebe0e834c11

Device Description

Elevating Leg Rest

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: 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
CCX	Support, Patient Position	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15593	Bed pillow, reusable	A sealed fabric case (e.g., cotton, pure wool) stuffed with soft material (e.g., down, polyester, foam, buckwheat husks) designed to support the head especially during rest and sleep in bed; it can also be used to support another part of the body to provide comfort (e.g., behind the back when in a sitting position, under a leg for support). It may or may not be used with a pillowcase and is laundered for cleaning between periods of use. It does not include antimicrobial/probiotic materials but might provide a physical barrier (e.g., tight weave) to dust mites; it is not dedicated to specialized applications/therapies. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10041298080807	GS1	Master carton	2	In Commercial Distribution
Primary	00041298080800	GS1