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ThermoChem

FDA UDI

Class II (US FDA UDI)

by Thermasolutions Llc.

Identity

Trade Name
ThermoChem FDA UDI
Generic Name
Intraperitoneal-circulation hypothermia system administration kit FDA UDI
Device Name
replacement sterile table pack in the event the sterility of the IPH table pack has been compromised. FDA UDI
Model / Reference
IPH Table Pack replacement FDA UDI
Description
replacement sterile table pack in the event the sterility of the IPH table pack has been compromised. FDA UDI

Identifiers

Catalog Number
111-3025 FDA UDI
Primary DI / UDI-DI
00851450007091 FDA UDI
FDA Product Code
MLW FDA UDI
GMDN Term
Intraperitoneal-circulation hypothermia system administration kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Depth — 4 Inch FDA UDI
Width — 16 Inch FDA UDI
Length — 16 Inch FDA UDI
Weight — 1 Pound FDA UDI

Category: Intraperitoneal-circulation hypothermia system administration kit

ThermoChem by Thermasolutions Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraperitoneal-circulation hypothermia system administration kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thermasolutions Llc.

Sources (1)

  • FDA UDI a6a2427d-e313-49e8-87fc-1ddbfd0c031b 36 fields · synced Jun 1, 2026