| Primary Device ID | 00862992000327 |
| NIH Device Record Key | d3e38c9b-d894-4886-b29b-183c655e9940 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | P2131-2 |
| Company DUNS | 178610390 |
| Company Name | FORT DEFIANCE INDUSTRIES, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 00862992000358 - NA | 2024-02-09 The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture- stable med |
| 00862992000341 - NA | 2023-08-10 The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture-stable medi |
| 00862992000303 - NA | 2018-07-06 The P2131 Automated Field Sterilizer (AFS) is an automated, pre- and post-vacuum steam sterilizer designed for sterilization of |
| 00862992000310 - NA | 2018-07-06 The P2131-1 Sterilizer Main Unit (SMU) is the sterilizer component of the P2131 Automated Field Sterilizer system. The P2131 is |
| 00862992000327 - NA | 2018-07-06The 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). |
| 00862992000327 - NA | 2018-07-06 The P2131-2 Water Recovery System (WRS) is the water recycling and vacuum source component of the P2131 Automated Field Steriliz |
| 00862992000334 - NA | 2018-07-06 The P2131-3 Sterilizer Water Softener (SWS) is the component that filters and de-mineralizes the incoming water to prevent scale |