HurriChem Device Kit

FDA UDI

Class II (US FDA UDI)

by Thermasolutions Llc.

Identity

Trade Name: HurriChem Device Kit FDA UDI
Generic Name: Atomizing surgical topical solution applicator FDA UDI
Device Name: HurriChem Device Kit is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris from the surgical site. FDA UDI
Model / Reference: PDT-5800 FDA UDI
Description: HurriChem Device Kit is indicated for use in patients undergoing a laparoscopic procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to lavage blood and tissue debris from the surgical site. FDA UDI

Identifiers

Primary DI / UDI-DI: 00851450007299 FDA UDI
510(k) Number: K222575 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Atomizing surgical topical solution applicator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 4.000 Centimeter FDA UDI
Width — 35.000 Centimeter FDA UDI
Depth — 15.000 Centimeter FDA UDI

Category: Atomizing surgical topical solution applicator

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Thermasolutions Llc.

Sources (1)

FDA UDI 4ad62638-be42-4a3a-b932-45bcabbbaf70 36 fields · synced May 30, 2026