FDA.reportPublic FDA data

HurriChem Device Kit

Primary DI
00851450007299
Brand
HurriChem Device Kit
Company
THERMASOLUTIONS, INC.
Model
PDT-5800
Device 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.
Published
2023-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222575000HurriChem Device KitThermasolutions, LLC2022-12-06GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851450007299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851450007299008514500072998514500072990851450007299

GMDN Terms#

Term, Definition table
TermDefinition
Atomizing surgical topical solution applicatorA sterile, hand-held manual surgical device intended to be used to apply a topical solution (e.g., medication) in the form of a mist/spray onto the mucosal or serosal surface of an exposed surgical site [e.g., during ear/nose/throat (ENT) or laparoscopic surgery]. It consists of a syringe connected to a cannula (e.g., via a Luer-lock), and contains a built-in atomizer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth15Centimeter
Height4Centimeter
Width35Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-209-3900info@thermasolutions.com

Regulatory Flags#

DUNS number
186855925
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851450007237ThermaSolutions FLW-01112023-06-09
00851450007244ThermaSolutions PAK-01122023-06-09
00851450007268ThermaSolutions FLW-00102023-06-09
00851450007305ThermaSolutions FLW-01202023-06-09
00851450007282ThermoChemIPH Procedure KItIPH-2000M2022-06-07
00851450007275ThermoChemIPH Procedure KitIPH-20002022-06-06
00851450007114ThermaSolutionsTMP-1304TMP-13042021-05-06
00851450007121ThermaSolutionsTMP-1308TMP-13082021-05-06
00851450007008ThermoChemHT-2000HT-20002016-09-16
00851450007015ThermoChemIPH Procedure Kit111-20002016-09-16
00851450007053ThermoChemHT-1000HT-10002016-09-16
00851450007091ThermoChemIPH Table Pack replacement111-30252017-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18