ManaMed

Basic Information

• Brand Name: ManaMed
• Primary DI: 00810113680170
• Version / Model: Bionic Sling Air Shoulder
• Catalog Number: BS001
• Company Name: MANAMED INC
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-20
• Public Version: 1
• Public Version Date: 2022-06-28
• Public Version Status: New
• Public Device Record Key: be98544b-03c8-44d7-a719-750165e34718

Device Description

The Bionic Sling is a universal shoulder sling with a continuous passive machine to promote small movements after shoulder surgeries to help patients recover quicker. Features and Benefits Universal sizing and can be applied to the left or right side Breathable material for patient comfort Provides support for shoulder surgeries or conservative care of shoulder injuries Passive Machine The pneumatic passive machine included with the shoulder sling To be worn to promote abduction movement with internal and external rotation Ability to achieve various abduction angles from 30 to 90 degrees The machine is portable, wireless, and rechargeable Common Examples of Use To promote small movements after rotator cuff, arthroscopic, and anterior repairs To prevent frozen shoulder Shoulder instabilities To be worn to eliminate the need for contracture braces

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: Yes
• 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
ILI	Sling, Arm	Physical Medicine	890.3640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12101	Shoulder immobilizer/orthosis, reusable	A prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113680170	GS1

Customer Contacts

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