3M™ Durapore™

Basic Information

• Brand Name: 3M™ Durapore™
• Primary DI: 30707387007448
• Version / Model: 1538-3
• Catalog Number: 1538-3
• Company Name: 3M COMPANY
• Labeler DUNS: 830016148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 2
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: d80ea934-d82d-4293-bdff-c64035e052e2

Device Description

3M™ Durapore™ Surgical Tape 3 inches x 10yards (7.6cm x 9.1m) 4Rolls/Carton 10Cartons/Case 1538-3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape and bandage, adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34831	Hypoallergenic skin adhesive tape	A flexible band of fabric, plastic, paper, or other material, coated on one side with a pressure-sensitive adhesive, and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic), intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter); it is not waterproof. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50707387772876	GS1	BOX	10	In Commercial Distribution
Primary	30707387007448	GS1
Unit of Use	08711428073676	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]