FDA.reportPublic FDA data

ThermoChem

Primary DI
00851450007091
Brand
ThermoChem
Company
THERMASOLUTIONS, INC.
Model
IPH Table Pack replacement
Catalog number
111-3025
Device description
replacement sterile table pack in the event the sterility of the IPH table pack has been compromised.
Published
2017-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MLWWarmer, Peritoneal Dialysate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLWWarmer, Peritoneal DialysateGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851450007091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851450007091008514500070918514500070910851450007091

GMDN Terms#

Term, Definition table
TermDefinition
Intraperitoneal-circulation hypothermia system administration kitA collection of sterile devices designed to be used in the function of an automated peritoneal lavage system (APLS). It typically includes tubing to connect the infusion/extraction pump mechanism of the control unit and the other components of the system [also known as the lavage administration set (LAS)], a peritoneal lavage catheter, a heat exchanger, a core body temperature probe (e.g., oesophageal), an infusate temperature sensor, a peritoneal pressure sensor, waste receptacle, and other appropriate devices for this treatment. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth4Inch
Length16Inch
Weight1Pound
Width16Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6512093900info@thermasolutions.com

Regulatory Flags#

DUNS number
186855925
Device count
1
Lot or batch
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
00851450007299HurriChem Device KitPDT-58002023-05-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851450007282ThermoChemTHERMASOLUTIONS, INC.MLW2022-06-07
00851450007275ThermoChemTHERMASOLUTIONS, INC.MLW2022-06-06
00851450007008ThermoChemTHERMASOLUTIONS, INC.MLW2016-09-16
00851450007015ThermoChemTHERMASOLUTIONS, INC.MLW2016-09-16
00851450007053ThermoChemTHERMASOLUTIONS, INC.MLW2016-09-16