FDA.reportPublic FDA data

3M™ Attest™

Primary DI
30707387785766
Brand
3M™ Attest™
Company
3M COMPANY
Model
1243RES
Catalog number
1243RES
Device description
"3M™ Attest™ Steam Chemical Integrator with 2"" Extender, 500/pack, 2 packs/case, 1243RES"
Published
2021-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOJIndicator, physical/chemical sterilization process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1912360003M™ Attest™ Steam Chemical Integrators3M Company2019-11-22JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50707387785760PackageGS12In Commercial Distribution
30707387785766PrimaryGS10
00707387785758Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5070738778576050707387785760
3070738778576630707387785766
00707387785758007073877857587073877857580707387785758

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
830016148
Device count
500
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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
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