FDA.reportPublic FDA data

NA

Primary DI
00862992000310
Brand
NA
Company
FORT DEFIANCE INDUSTRIES, LLC
Model
P2131-1
Device description
The P2131-1 Sterilizer Main Unit (SMU) is the sterilizer component of 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).
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLESterilizer, Steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141009000FORT DEFIANCE AUTOMATED STEAM STERILIZERFort Defiance Industries, Inc.2014-12-16FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862992000310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862992000310008629920003108629920003100862992000310

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height62Inch
Length38Inch
Weight295Pound
Width26.75Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
865-408-0100techsupport@fortdefianceind.com

Regulatory Flags#

DUNS number
178610390
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862992000358NAFRONT-LINE FL1352024-02-01
00862992000341NAFRONT-LINE FL1202023-08-02
00862992000303NAP21312016-09-20
00862992000327NAP2131-22016-09-20
00862992000334NAP2131-32016-09-20

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