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Pt9

FDA UDI

Class II (US FDA UDI)

by Thermotek, Inc.

Identity

Trade Name
PT9 FDA UDI
Generic Name
Single-chamber venous compression system garment, reusable FDA UDI
Device Name
PT9 Therapy System FDA UDI
Model / Reference
0P9PT09SYS FDA UDI
Description
PT9 Therapy System FDA UDI

Identifiers

Catalog Number
0P9PT09SYS FDA UDI
Primary DI / UDI-DI
B5850P9PT09SYS0 FDA UDI
FDA Product Code
JOW FDA UDI
ILO FDA UDI
GMDN Term
Single-chamber venous compression system garment, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5800 FDA UDI
890.5720 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Circulating-fluid localized thermal therapy system pack, single-useCirculating-fluid localized thermal/compression therapy system wrapCirculating-fluid localized thermal/compression therapy system control unitSingle-chamber venous compression system garment, reusable

Pt9 by Thermotek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Single-chamber venous compression system garment, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thermotek, Inc.

Sources (1)

  • FDA UDI 0c01aa92-36cf-4c04-b1be-ae848e9b4ff2 35 fields · synced Jun 6, 2026