FDA.report

American White Cross

Primary DI
30665973018271
Brand
American White Cross
Company
Dukal LLC
Model
2040033
Catalog number
2040033
Device description
Waterproof Tape 1" x 5 yd
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KGXTape and bandage, adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20665973018274PackageGS14In Commercial Distribution
30665973018271PackageGS112In Commercial Distribution
10665973018277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2066597301827420665973018274
3066597301827130665973018271
1066597301827710665973018277

GMDN Terms

TermDefinition
Dressing-fixation skin adhesive tape, non-siliconeA long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags

DUNS number
791014871
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
false

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30665973032550UnipackUPP-7513UPP-75132025-06-01

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