FDA.reportPublic FDA data

3M™ Nexcare™ Active™

Primary DI
50051131997177
Brand
3M™ Nexcare™ Active™
Company
3M COMPANY
Model
511-08
Catalog number
511-08
Device description
Nexcare™ Active™ Waterproof Bandages, Knee and Elbow, 511-08, , 8 ct.
Published
2018-09-25
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
KGXTape and bandage, adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50051131997177PackageGS14In Commercial Distribution
00051131208179PrimaryGS10
00051131997172Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5005113199717750051131997177
00051131208179000511312081790511312081790051131208179
00051131997172000511319971720511319971720051131997172

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)537-21913Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
830016148
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
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007073877918893M™ Cavilon™3344ENS3344ENS2022-12-08
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10608223645007Bair Hugger™64500645002016-09-24
507073878140263M™ Ioban™8840EZ8840EZ2025-01-17
507073878140333M™ Ioban™8850EZ8850EZ2025-01-17
307073878140463M™ Ioban™8851EZ8851EZ2025-01-17
507073878140573M™ Ioban™8840EZSB8840EZSB2025-01-17
507073878140643M™ Ioban™8850EZSB8850EZSB2025-01-17
507073878140713M™ Ioban™8851EZSB8851EZSB2025-01-17
507073875674653M™861186112026-02-19
507073877738733M™861086102026-02-19
506058610858733M™6550A16550A12025-09-09
506058610858803M™6550A26550A22025-09-09
506058610858973M™6550A36550A32025-09-09
506058610859033M™6550A3.56550A3.52025-09-09
506058610859103M™6550A46550A42025-09-09
506058610859273M™6550B16550B12025-09-09
506058610859343M™6550B26550B22025-09-09
506058610859413M™6550D36550D32025-09-09

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