ManaMed

Basic Information

• Brand Name: ManaMed
• Primary DI: 00810113680729
• Version / Model: ManaEZ Sling XX-Large
• Catalog Number: EZSL01XXL
• 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: 988de014-1f1f-48ca-916a-6e2ab4461101

Device Description

The ManaEZ sling is a convenient, comfortable, and simple way to immobilize the shoulder and elbow. The over the shoulder strap is made out of comfortable material for the optimal patient experience. For non-surgical or post-op support and immobilization of the shoulder. Simple and comfortable

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	00810113680729	GS1

Customer Contacts

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