NA - The P2131-2 Water Recovery System (WRS) is the - FORT DEFIANCE INDUSTRIES, LLC

Duns Number:178610390

Device Description: The P2131-2 Water Recovery System (WRS) is the water recycling and vacuum source component The P2131-2 Water Recovery System (WRS) is the water recycling and vacuum source component of the P2131 Automated Field Sterilizer system. The WRS reclaims hot condensate and exhaust steam for re-use by the sterilizer. The WRS also includes a water eductor, which provides the vacuum capability for the pre and post-vacuum phases of sterilization. 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).

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

P2131-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K141009

Product Code Details

Product Code

FLE

Product Code Name

Sterilizer, Steam

Device Record Status

Public Device Record Key

d3e38c9b-d894-4886-b29b-183c655e9940

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FORT DEFIANCE INDUSTRIES, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4