SLEEP SYSTEM NITETIME

Basic Information

• Brand Name: SLEEP SYSTEM NITETIME
• Primary DI: 05050962293700
• Version / Model: LOWER LIMB POSITIONING ITEMS
• Catalog Number: SA5530
• Company Name: THE HELPING HAND COMPANY (LEDBURY) LIMITED
• Labeler DUNS: 397307240
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-02
• Public Version: 1
• Public Version Date: 2024-02-12
• Public Version Status: New
• Public Device Record Key: 380a47f5-755c-4186-b5a6-ce1258c8ec84

Device Description

SLEEP SYSTEM NITETIME

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
FNJ	Bed, Manual	General Hospital	880.5120	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63407	Assistive sleeping cushion set	A collection of cushions, pads, pillows and bolsters intended to provide support and optimal positioning for a disabled person during sleep. The items are typically made of soft textile or synthetic materials and include pieces designed for specific body parts (e.g., head, shoulders, back, hips, knees, feet) used during different sleeping positions (supine, side, or prone lying). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05050962293700	GS1

Customer Contacts

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