Bodyfix

Basic Information

• Brand Name: Bodyfix
• Primary DI: 08436035354191
• Version / Model: BFX8000
• Company Name: MEDI CARE SYSTEM SLU
• Labeler DUNS: 511139446
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-22
• Public Version: 1
• Public Version Date: 2019-12-02
• Public Version Status: New
• Public Device Record Key: 91308c8a-08f0-42f0-a3a1-5124f5c8d880

Device Description

Body Cover for patient's care Blue

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMQ	Restraint, protective	General Hospital	880.6760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35602	Assistive nightwear	A garment specially designed/adapted to be worn by a person with a disability while sleeping at night. It may be a one-piece garment (a nightgown) or a two-piece garment (pyjamas) typically constructed with features that facilitate easy donning, fastening, and removal (e.g., wide sleeves or trouser legs, Velcro and zip fasteners), and sometimes with specially-made openings/flaps for visits to the toilet.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08436035354191	GS1

Customer Contacts

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