Multi-FLO DVT Combo Cyro Shoulder Sleeve

Basic Information

• Brand Name: Multi-FLO DVT Combo Cyro Shoulder Sleeve
• Primary DI: 00812311020512
• Version / Model: GC1-3035-SH
• Company Name: Bio Compression Systems, Inc
• Labeler DUNS: 101393924
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-09
• Public Version: 2
• Public Version Date: 2020-01-29
• Public Version Status: Update
• Public Device Record Key: e48a6443-ab0b-4985-ab3a-b2b3bc4ffa41

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
JOW	SLEEVE, LIMB, COMPRESSIBLE	Cardiovascular	870.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30877	Single-chamber venous compression system garment, reusable	An inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the intermittent inflation of a single-chamber. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a reusable device.	No	Active
37240	Hot/cold therapy pack, reusable	A non-sterile 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. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812311020512	GS1

Premarket Submissions

Submission Number	Supplement Number
K131306	000