FDA.reportPublic FDA data

Envirosystems

Primary DI
50724995010336
Brand
Envirosystems
Company
STERIS CORPORATION
Model
PB013
Catalog number
PB013
Device description
The Envirosystems Ethylene Oxide (EO) Sterilant gas cartridge is a single-unit dose for the Amsco Eagle 3017 EO Sterilizer.
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLFSterilizer, ethylene-oxide gas

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLFSterilizer, Ethylene-Oxide GasGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931872000THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERAmerican Sterilizer Co.1994-02-07FLF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50724995010336PrimaryGS10
00724995010331Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499501033650724995010336
00724995010331007249950103317249950103310724995010331

GMDN Terms#

Term, Definition table
TermDefinition
Ethylene oxide device sterilantA gaseous substance that includes ethylene oxide (ETO) as its primary agent to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight100Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature. Do not contaminate water, food, or feed by storage or disposal

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
139424188
Device count
12
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060485030706AN4000.60 EOGas 4 Ethylene Oxide Gas Sterilizer, 115VANDERSEN STERILIZERS INC.FLF2023-08-31
05060485030713AN4000.61 EOGas 4 Ethylene Oxide Gas Sterilizer, 230VANDERSEN STERILIZERS INC.FLF2023-08-31
05060485030744AN4000.67 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 230VANDERSEN STERILIZERS INC.FLF2023-08-31
10705037067244SEALSURE™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLF2021-02-11
007073877870113M™ Steri-Vac™3M COMPANYFLF2020-10-22
007073877870283M™ Steri-Vac™3M COMPANYFLF2020-10-22
007073877875613M™ Steri-Vac™3M COMPANYFLF2020-10-22
007073877875783M™ Steri-Vac™3M COMPANYFLF2020-10-22
05060485030607Anprolene AN75 Ethylene Oxide SterilizerANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030614Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230VANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030621Anprolene AN75 Ethylene Oxide Sterilizer, 115VANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030638Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230VANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030669Anprolene AN75 Refill Kit, 14 UnitsANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030164 EOGas 4 Refill KitANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030331AN1071 HumidichipANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030393EOGas 4 Ethylene Oxide Gas SterilizerANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030409EOGas 4 Ethylene Oxide Gas SterilizerANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030416EOGas 4 Sterilization BagANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030430AN1071 HumidichipANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030447EOGas 4 Refill KitANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030454EOGas 4 Refill KitANDERSEN STERILIZERS INC.FLF2018-09-01
10705037014583STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLF2016-09-24
10705037014651SterradADVANCED STERILIZATION PRODUCTS SERVICES INC.FLF2016-09-24
20705037014658SterradADVANCED STERILIZATION PRODUCTS SERVICES INC.FLF2016-09-24
10705037014460SterradADVANCED STERILIZATION PRODUCTS SERVICES INC.FLF2016-09-24
50707387767247Steri-Vac™3M COMPANYFLF2016-09-24
50707387767254Steri-Vac™3M COMPANYFLF2016-09-24
50707387767261Steri-Vac™3M COMPANYFLF2016-09-24
50707387767278Steri-Vac™3M COMPANYFLF2016-09-24
00724995152017Amsco EagleSteris Mexico, S. de R.L. de C.V.FLF2016-09-14