PT9 - BEUDAMED

Basic Information

Brand Name: PT9
Primary DI: B5850P9PT09SYS0
Version / Model: 0P9PT09SYS
Catalog Number: 0P9PT09SYS
Company Name: THERMOTEK, INC.
Labeler DUNS: 847899911
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2019-03-04
Public Version: 2
Public Version Date: 2023-12-18
Public Version Status: Update
Public Device Record Key: 0c01aa92-36cf-4c04-b1be-ae848e9b4ff2

Device Description

PT9 Therapy System

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
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: Yes
Has Serial Number: Yes
Has Lot/Batch Number: No
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
JOW	Sleeve, Limb, Compressible	Cardiovascular	870.5800	2
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	890.5720	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
40485	Circulating-fluid localized thermal therapy system pack, single-use	A device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a single-use device.	No	Active
60708	Circulating-fluid localized thermal/compression therapy system wrap	A non-sterile component of a circulating-fluid localized thermal/compression therapy system intended to facilitate, through thermal therapy (heating and/or cooling) and compression, the treatment of a variety of adverse conditions resulting from a musculoskeletal injury/orthopaedic surgery (e.g., pain, swelling, inflammation). It is intended to be fastened around a single or multiple anatomies and consists of: a heat exchanger, which enables heated and/or cooled fluid from the system control unit to be circulated; and an external sleeve, which enables intermittent compression via inflation. It is intended for use in both professional and home settings. This is a reusable device.	No	Active
60707	Circulating-fluid localized thermal/compression therapy system control unit	An electrically-powered device intended to pump heated and/or cooled water through an externally applied wrap (not included), and to air inflate the wrap, for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury and/or orthopaedic surgery (e.g., pain, swelling, inflammation). It includes a fluid pump, air pump, controls, and either a heater or a means for cold therapy (e.g., refrigeration unit, addition of independently cooled ice water) or both. The unit may be programmable for selected treatment plans. It is intended for use in both professional and home settings.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B5850P9PT09SYS0	HIBCC

Customer Contacts

Phone: 972-874-4949
Email: [email protected]