GUDID 00862992000334

The P2131-3 Sterilizer Water Softener (SWS) is the component that filters and de-mineralizes the incoming water to prevent scale build-up in the P2131 Automated Field Sterilizer system. The P2131 is an automated, pre- and post-vacuum steam sterilizer designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for field use in a variety of austere environments. The P2131 sterilizer consists of three components that work together as one integrated system. These components are the (1) Sterilizer Main Unit (SMU), (2) Water Recovery System (WRS), and (3) the Sterilizer Water Softener (SWS).

FORT DEFIANCE INDUSTRIES, LLC

Steam sterilizer
Primary Device ID00862992000334
NIH Device Record Key0ca6544c-64f7-4294-9e0e-609238e80340
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberP2131-3
Company DUNS178610390
Company NameFORT DEFIANCE INDUSTRIES, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone865-408-0100
Emailtechsupport@fortdefianceind.com

Device Dimensions

Length20 Inch
Length20 Inch
Length20 Inch
Length20 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100862992000334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLESterilizer, Steam

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

Devices Manufactured by FORT DEFIANCE INDUSTRIES, LLC

00862992000358 - NA2024-02-09 The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture- stable med
00862992000341 - NA2023-08-10 The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture-stable medi
00862992000303 - NA2018-07-06 The P2131 Automated Field Sterilizer (AFS) is an automated, pre- and post-vacuum steam sterilizer designed for sterilization of
00862992000310 - NA2018-07-06 The P2131-1 Sterilizer Main Unit (SMU) is the sterilizer component of the P2131 Automated Field Sterilizer system. The P2131 is
00862992000327 - NA2018-07-06 The P2131-2 Water Recovery System (WRS) is the water recycling and vacuum source component of the P2131 Automated Field Steriliz
00862992000334 - NA2018-07-06The P2131-3 Sterilizer Water Softener (SWS) is the component that filters and de-mineralizes the incoming water to prevent scale build-up in the P2131 Automated Field Sterilizer system. The P2131 is an automated, pre- and post-vacuum steam sterilizer designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for field use in a variety of austere environments. The P2131 sterilizer consists of three components that work together as one integrated system. These components are the (1) Sterilizer Main Unit (SMU), (2) Water Recovery System (WRS), and (3) the Sterilizer Water Softener (SWS).
00862992000334 - NA2018-07-06 The P2131-3 Sterilizer Water Softener (SWS) is the component that filters and de-mineralizes the incoming water to prevent scale
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