Unite Medical®

Basic Information

• Brand Name: Unite Medical®
• Primary DI: 00850012035312
• Version / Model: Cryo Pneumatic Shoulder - Universal
• Catalog Number: Cyro3670
• Company Name: Unite Medical, LLC
• Labeler DUNS: 117553945
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-20
• Public Version: 2
• Public Version Date: 2026-01-12
• Public Version Status: Update
• Public Device Record Key: 76d4d2a9-498a-4b00-a4d3-e375a30af162

Device Description

The Unite Medical® Cryo Pneumatic Shoulder orthosis combines pneumatic compression with cold therapy in a universal design. Indicated for post-op application or as an adjuct to a physical therapy regime, the Cryo Pneumatic Shoulder orthosis offers a wide variety of treatment options. Aids in the reduction of swelling, reduced muscle spasms, and pain relief.

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: Yes
• 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
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	890.3420	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
37240	Musculoskeletal hot/cold therapy pack, reusable	A non-powered device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck, nor is it designed to be dedicated to eye thermal therapy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850012035312	GS1

Customer Contacts

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