FDA.reportPublic FDA data

3M™ Cavilon™

Primary DI
50707387809763
Brand
3M™ Cavilon™
Company
3M COMPANY
Model
3344E
Catalog number
3344E
Device description
FREE_FROM_LATEX
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMFBandage, liquid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMFBandage, LiquidGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K9551030003M NO STING BARRIER FILM3M Medical Products Group1996-02-05KMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50707387809763PackageGS16In Commercial Distribution
00707387809768PrimaryGS10
00707387809751Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5070738780976350707387809763
00707387809768007073878097687073878097680707387809768
00707387809751007073878097517073878097510707387809751

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic-polymer liquid barrier dressingA liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
830016148
Device count
30
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10192253047967KendallCardinal Health 200, LLCKMF2026-05-26
10192253047974KendallCardinal Health 200, LLCKMF2026-05-13
10192253047943KendallCardinal Health 200, LLCKMF2026-05-12
10192253047950KendallCardinal Health 200, LLCKMF2026-05-12
007073878171523M™ Cavilon™3M COMPANYKMF2026-04-17
00858071004034Natural Seal Wound Dressing 1ozKericure Inc.KMF2025-10-03
00858071004256Advanced Seal Wound Barrier, 1oz sprayKericure Inc.KMF2025-08-21
00860013046415TearRepairOptmed IncKMF2025-05-30
10888277719743MedlineMEDLINE INDUSTRIES, INC.KMF2024-03-05
20888277719740MedlineMEDLINE INDUSTRIES, INC.KMF2024-03-05
10192253048087KendallCardinal Health 200, LLCKMF2024-03-04
10192253048094KendallCardinal Health 200, LLCKMF2024-03-04
10192253048100KendallCardinal Health 200, LLCKMF2024-03-04
10192253048117KendallCardinal Health 200, LLCKMF2024-03-04
20192253048084KendallCardinal Health 200, LLCKMF2024-03-04
20192253048091KendallCardinal Health 200, LLCKMF2024-03-04
20192253048107KendallCardinal Health 200, LLCKMF2024-03-04
20192253048114KendallCardinal Health 200, LLCKMF2024-03-04
10192253046908CurityCardinal Health 200, LLCKMF2023-11-03
20192253046905CurityCardinal Health 200, LLCKMF2023-11-03
10192253046861CurityCardinal Health 200, LLCKMF2023-10-25
10192253046885CurityCardinal Health 200, LLCKMF2023-10-25
20192253046875CurityCardinal Health 200, LLCKMF2023-10-25
20192253046868CurityCardinal Health 200, LLCKMF2023-10-25
20192253046882CurityCardinal Health 200, LLCKMF2023-10-25
30192253046872CurityCardinal Health 200, LLCKMF2023-10-25
10192253046847CurityCardinal Health 200, LLCKMF2023-10-24
10192253046854CurityCardinal Health 200, LLCKMF2023-10-24
20192253046844CurityCardinal Health 200, LLCKMF2023-10-24
20192253046851CurityCardinal Health 200, LLCKMF2023-10-24