Envirosystems PB013

GUDID 50724995010336

The Envirosystems Ethylene Oxide (EO) Sterilant gas cartridge is a single-unit dose for the Amsco Eagle 3017 EO Sterilizer.

STERIS CORPORATION

Ethylene oxide device sterilant
Primary Device ID50724995010336
NIH Device Record Key26c80342-b718-4555-a3d8-60ec65ef5952
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnvirosystems
Version Model NumberPB013
Catalog NumberPB013
Company DUNS139424188
Company NameSTERIS CORPORATION
Device Count12
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx

Device Dimensions

Weight100 Gram
Weight100 Gram
Weight100 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not contaminate water, food, or feed by storage or disposal
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not contaminate water, food, or feed by storage or disposal
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Do not contaminate water, food, or feed by storage or disposal

Device Identifiers

Device Issuing AgencyDevice ID
GS100724995010331 [Unit of Use]
GS150724995010336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLFSterilizer, ethylene-oxide gas

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-28
Device Publish Date2016-09-08

Devices Manufactured by STERIS CORPORATION

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00724995243654 - ORLocate2025-04-25 OrLocate Reader Box is used with the ORLocate Sponge Solution System.
00724995243678 - ORLocate2025-04-25 The ORLocate Roll Stand is part of the ORLocate Sponge System.
00724995243685 - ORLocate2025-04-25 ORLocate Sponge Solution is an innovative counting and locating technology that enhances patient safety and reduces time spent c
00724995243692 - ORLocate2025-04-25 Medical Grade Tablet with 11.6 inch screen is used with the ORLocate Sponge Solution System.
00724995220631 - ORLocate2025-04-18 The ORLocate Components Pack contains the ORLocate Locator, ORLocate HoveRead, ORLocate Reader Box, and Advantech Medical Panel

Trademark Results [Envirosystems]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENVIROSYSTEMS
ENVIROSYSTEMS
86092983 5527200 Live/Registered
Envirosystems Inc.
2013-10-16
ENVIROSYSTEMS
ENVIROSYSTEMS
77681064 not registered Dead/Abandoned
Envirosystems Inc.
2009-03-02
ENVIROSYSTEMS
ENVIROSYSTEMS
77439721 3664556 Live/Registered
CYPRESS ENVIROSYSTEMS, INC.
2008-04-03
ENVIROSYSTEMS
ENVIROSYSTEMS
76700542 3918367 Dead/Cancelled
ENVIROSYSTEMS LLC
2009-11-25
ENVIROSYSTEMS
ENVIROSYSTEMS
75357708 not registered Dead/Abandoned
Stripping Technologies, Inc.
1997-09-16
ENVIROSYSTEMS
ENVIROSYSTEMS
74451772 1891392 Dead/Cancelled
SAFETY-KLEEN SYSTEMS, INC.
1993-10-28
ENVIROSYSTEMS
ENVIROSYSTEMS
74359534 1799020 Live/Registered
INDUSCO, LTD.
1993-02-16
ENVIROSYSTEMS
ENVIROSYSTEMS
73064739 1060130 Dead/Cancelled
Envirosystems Corporation
1975-10-01

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