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Tpt9

FDA UDI

Class II (US FDA UDI)

by C2dx, Inc.

Identity

Trade Name
TPT9 FDA UDI
Generic Name
Circulating-fluid localized thermal therapy system pack, reusable FDA UDI
Device Name
Water Flow and Temperature Tester FDA UDI
Model / Reference
TPT9 FDA UDI
Description
Water Flow and Temperature Tester FDA UDI

Identifiers

Primary DI / UDI-DI
00850007350161 FDA UDI
510(k) Number
K073675 FDA UDI
FDA Product Code
ILO FDA UDI
GMDN Term
Circulating-fluid localized thermal therapy system pack, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Circulating-fluid localized thermal therapy system pack, reusable

Tpt9 by C2dx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circulating-fluid localized thermal therapy system pack, reusable.

Cleared under the same submission

K073675 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
C2dx, Inc.

Sources (1)

  • FDA UDI 271bb502-64f3-46e3-a2b8-341eb57c69f8 35 fields · synced May 30, 2026