SleepSafe

Basic Information

• Brand Name: SleepSafe
• Primary DI: 10860000213711
• Version / Model: Fixed
• Company Name: SLEEPSAFE BEDS, LLC
• Labeler DUNS: 613022636
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-22
• Public Version: 1
• Public Version Date: 2019-07-30
• Public Version Status: New
• Public Device Record Key: 0ed822c1-665b-4eaf-9c0e-9401e2639fb4

Device Characteristics

• Single Use: Yes
• 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
FNJ	Bed, Manual	General Hospital	880.5120	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34873	Manual hospital bed	A mechanical bed designed to be used as a patient bed for rest/sleep in a hospital ward/room with manual mechanisms to adjust the height and surface contour of the bed. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and mechanical manually-operated controls to operate the bed.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10860000213711	GS1