FDA.reportPublic FDA data

3M™ Steri-Vac™

Primary DI
00707387787578
Brand
3M™ Steri-Vac™
Company
3M COMPANY
Model
GS5-2D
Catalog number
GS5-2D
Device description
3M™ Steri-Vac™ Sterilizer/Aerator GS Series, GS5-2D
Published
2020-10-22
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
FLFSterilizer, ethylene-oxide gas

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1420340003M STERI-VAC STERILIZER/AERATOR3M Company2015-01-08FLF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00707387787578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00707387787578007073877875787073877875780707387787578

GMDN Terms#

Term, Definition table
TermDefinition
Ethylene oxide sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using ethylene oxide (ETO) gas with low humidity content as the sterilizing agent; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris and packed in gas permeable wraps; a means to introduce the gas into the chamber; and controls to chose one of the sterilization cycles. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-39573Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
830016148
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
007073877752543M™ Bair Hugger™30077300772026-05-15
007073877752613M™ Bair Hugger™31077310772026-05-15
007073877752853M™ Bair Hugger™53777537772026-05-15
007073877753083M™ Bair Hugger™55077550772026-05-15
007073877753153M™ Bair Hugger™55577555772026-05-15
007073878188833M™ Bair Hugger™54501545012026-05-15
007073878188903M™ Bair Hugger™55001550012026-05-15
007073878189063M™ Bair Hugger™55502555022026-05-15
007073878189133M™ Bair Hugger™58502585022026-05-15
007073878189203M™ Bair Hugger™63501635012026-05-15
007073878189373M™ Bair Hugger™57502575022026-05-15
007073878189443M™ Bair Hugger™45035450352026-05-15
007073878189513M™ Bair Hugger™45535455352026-05-15
007073878189683M™ Bair Hugger™55078550782026-05-15
007073878189753M™ Bair Hugger™55578555782026-05-15
106058610760643M™ Filtek™6555A3-S6555A3-S2026-05-08
106058610773823M™ Filtek™4867A14867A12026-05-08
106058610773993M™ Filtek™4867A24867A22026-05-08
106058610774053M™ Filtek™4867A34867A32026-05-08
106058610774123M™ Filtek™4867B14867B12026-05-08

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
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
50724995010336EnvirosystemsSTERIS CORPORATIONFLF2016-09-08