Black Boot

Basic Information

• Brand Name: Black Boot
• Primary DI: 00817369020163
• Version / Model: 5 Cell Extra Long Boot Black
• Catalog Number: 20006
• Company Name: NORMATEC INDUSTRIES LP
• Labeler DUNS: 111448069
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 78227011-886f-4a6a-ac54-4c2aa10a434b

Device Description

5 Cell Extra Long Boot Black

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
IRP	Massager, Powered Inflatable Tube	Physical Medicine	890.5650	2
JOW	Sleeve, Limb, Compressible	Cardiovascular	870.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10969	Intermittent venous compression system	A system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit.	No	Active
16837	Sequential venous compression system	A system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by applying sequential pressure to a patient's legs to promote venous blood flow. It consists of a compression pump, control/timing mechanism, tubing and has pneumatic stockings, sleeves, or a suit with several chambers that inflate and deflate sequentially in a pattern beginning at the foot or ankle and continuing to chambers around the calf and thigh. In some systems, each chamber reaches the same pressure but at different times, while others apply greater pressure distally which gradually diminishes higher up.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817369020163	GS1

Premarket Submissions

Submission Number	Supplement Number
K013436	000
K112890	000