Ouch Essentials 17061001

GUDID 20665973026484

Kiddo Care Kit

Dukal LLC

Skin-cover adhesive strip, non-antimicrobial

• Primary Device ID: 20665973026484
• NIH Device Record Key: 9d0d4730-7bfd-41c3-ac63-430720ddbc2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ouch Essentials
• Version Model Number: 17061001
• Catalog Number: 17061001
• Company DUNS: 791014871
• Company Name: Dukal LLC
• Device Count: 200
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com
• Phone: +1(631)656-3800
• Email: kmckigney@dukal.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00665973026480 [Primary]
GS1	10665973026487 [Unit of Use]
GS1	20665973026484 [Package]; Contains: 00665973026480; Package: Case [12 Units]; In Commercial Distribution

FDA Product Code

• KGX: Tape and bandage, adhesive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-30
• Device Publish Date: 2024-08-22

Devices Manufactured by Dukal LLC

• 30665973032307 - DUKAL: 2024-12-11 Antimicrobial Bandage Roll 4.5"x4.1yd, Sterile
• 20665973032171 - RENCURA: 2024-11-12 Calcium Alginate Dressing 2X2
• 20665973032188 - RENCURA: 2024-11-12 Calcium Alginate Dressing 4X4
• 20665973032195 - RENCURA: 2024-11-12 Calcium Alginate Dressing 6x6
• 30665973032208 - RENCURA: 2024-11-12 Calcium Alginate Dressing 4X8
• 30665973032215 - RENCURA: 2024-11-12 Calcium Alginate Dressing 1X12 Rope
• 20665973032225 - RENCURA: 2024-11-12 Calcium Alginate Dressing with Silver 2X2
• 30665973032239 - RENCURA: 2024-11-12 Calcium Alginate Dressing with Silver 4X4