FDA.reportPublic FDA data

BAND-AID Brand Adhesive Bandages

Primary DI
00381371166282
Brand
BAND-AID Brand Adhesive Bandages
Company
JOHNSON & JOHNSON CONSUMER INC.
Model
00381371166282
Device description
BANDAID First Aid Non Stick Gauze Pad 4.5 X 5.5 Large 4 Count
Published
2019-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00381371166282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00381371166282003813711662823813711662820381371166282

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze pad, sterileA non-medicated sterile device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)565-2873xxx@xxx.com

Regulatory Flags#

DUNS number
002347102
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00381372020651BAND-AID Brand Adhesive Bandages003813720206512022-03-01
00381372020071BAND-AID Brand Adhesive Bandages003813720200712022-02-01
00381372020088BAND-AID Brand Adhesive Bandages003813720200882022-02-01
00381372020378BAND-AID Brand Adhesive Bandages003813720203782022-01-03
00381372020385BAND-AID Brand Adhesive Bandages003813720203852022-01-03
00381372020538BAND-AID Brand Adhesive Bandages003813720205382022-01-01
00381372020545BAND-AID Brand Adhesive Bandages003813720205452022-01-01
00381372020552BAND-AID Brand Adhesive Bandages003813720205522022-01-01
00381372020569BAND-AID Brand Adhesive Bandages003813720205692022-01-01
00381372020897BAND-AID Brand Adhesive Bandages003813720208972022-01-01
00012547386462Listerine000125473864622018-09-12
00012547440188Listerine000125474401882018-09-12
00012547440195Listerine000125474401952018-09-12
00012547440287Listerine000125474402872018-09-12
00012547440362Listerine000125474403622018-09-12
00381372020613BAND-AID Brand Adhesive Bandages003813720206132021-10-04
00381372020873BAND-AID Brand Adhesive Bandages003813720208732021-10-04
00381372020606BAND-AID Brand Adhesive Bandages003813720206062021-09-06
00381372020620BAND-AID Brand Adhesive Bandages003813720206202021-09-06
00381372020835BAND-AID Brand Adhesive Bandages003813720208352021-09-06

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