FDA.reportPublic FDA data

3M™ Tegaderm™

Primary DI
50707387506761
Brand
3M™ Tegaderm™
Company
3M COMPANY
Model
90601
Catalog number
90601
Device description
3M(TM) Tegaderm(TM) Foam Dressing (nonadhesive) 90601
Published
2018-09-24
Public version status
Update
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
NACDressing, wound, hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50707387506761PackageGS14In Commercial Distribution
08711428082753PrimaryGS10
00707387506766Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5070738750676150707387506761
08711428082753087114280827538711428082753
00707387506766007073875067667073875067660707387506766

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). 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
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
088877192573983M™186018602016-08-03
088877192574043M™1860S1860S2016-08-03
506380604335343M™ Aura™1870+1870+2022-06-02
000511312755393M™186018602016-08-03
000511312755463M™1860S1860S2016-08-03
00051131498556VFlex™180518052016-08-03
00051131498563VFlex™1805S1805S2016-08-03
00051131499966Aura™1870+1870+2016-08-03
000680608569683M186018602024-10-25
000680608581223M1860S1860S2024-10-25
006380604309583M™ Aura™1870+1870+2021-08-26
006380604313443M™ Aura™1870+BULK1870+BULK2020-10-22
006380604335463M™ Aura™1870+1870+2022-06-02
007073874194243M™186018602016-08-03
007073874441293M™1860S1860S2016-08-03
300511312759293M™ Vflex™180418042018-02-21
300511312759363M™ Vflex™1804S1804S2018-02-21
007073877752543M™ Bair Hugger™30077300772026-05-15
007073877752613M™ Bair Hugger™31077310772026-05-15
007073877752853M™ Bair Hugger™53777537772026-05-15

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