Redicare

Basic Information

• Brand Name: Redicare
• Primary DI: B70903050060
• Version / Model: Redisplint Conforming Splint
• Catalog Number: 0305006
• Company Name: REDICARE LLC
• Labeler DUNS: 800149346
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-28
• Public Version: 1
• Public Version Date: 2020-08-05
• Public Version Status: New
• Public Device Record Key: 25de8351-61cb-412a-b597-aeea87fd1400

Device Description

4.25" x 24" Padded Aluminum Conforming Splint

Device Characteristics

• Single Use: Yes
• 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
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	878.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64881	First aid limb splint, mouldable, single-use	A portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It takes the form of a semi-rigid, padded, metallic sheet, or a wire frame, or a thermoplastic material designed to be manually moulded/curved externally around the limb to create a rigid splint. It is typically intended to be used by emergency medical services (EMS). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B70903050061	HIBCC	CASE	200	In Commercial Distribution
Primary	B70903050060	HIBCC

Device Sizes

Type	Value	Unit	Text
Width	4.25	Inch
Length	24	Inch