Solventum™ Durapore™ 1538-2

GUDID 00197998052217

Solventum™ Durapore™ Surgical Tape, 1538-2, 5 cm x 9,1 m (2 IN/PO x 10YD/V), 6/CAR

Solventum US LLC

Dressing-fixation skin adhesive tape, non-silicone

• Primary Device ID: 00197998052217
• NIH Device Record Key: f5b20cbd-32ce-45c0-b2e6-1c02fafec299
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solventum™ Durapore™
• Version Model Number: 1538-2
• Catalog Number: 1538-2
• Company DUNS: 119004140
• Company Name: Solventum US LLC
• Device Count: 6
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197998052194 [Unit of Use]
GS1	00197998052200 [Primary]
GS1	00197998052217 [Package]; Contains: 00197998052200; Package: CASE [10 Units]; In Commercial Distribution

FDA Product Code

• KGX: Tape and bandage, adhesive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-23
• Device Publish Date: 2026-02-15

On-Brand Devices [Solventum™ Durapore™]

• 00197998052576: Solventum™ Durapore™ Surgical Tape, 1538S-1, 2,5 cm x 1,3 m (1 IN/PO x1.5 YD/V), 100/CAR
• 00197998052293: Solventum™ Durapore™ Surgical Tape, 1538-0, 1,25 cm x 9,1 m (0.5 IN/PO x10 YD/V), 24/CAR
• 00197998052255: Solventum™ Durapore™ Surgical Tape, 1538-1, 2,5 cm x 9,1 m (1 IN/PO x 10YD/V), 12/CAR
• 00197998052217: Solventum™ Durapore™ Surgical Tape, 1538-2, 5 cm x 9,1 m (2 IN/PO x 10YD/V), 6/CAR
• 00197998052170: Solventum™ Durapore™ Surgical Tape, 1538-3, 7,6 cm x 9,1 m (3 IN/PO x 10YD/V), 4/CAR