Dukal 1580

GUDID 20665973028891

Surgical Mask, Level 2, Blue Earloop, NS

DUKAL CORPORATION

Surgical/medical face mask, non-antimicrobial, single-use

• Primary Device ID: 20665973028891
• NIH Device Record Key: 2b4bd7da-0aaf-4c3d-85b3-4f2cb30e3379
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dukal
• Version Model Number: 1580
• Catalog Number: 1580
• Company DUNS: 791014871
• Company Name: DUKAL CORPORATION
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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
• 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	00665973028897 [Unit of Use]
GS1	10665973028894 [Primary]
GS1	20665973028891 [Package]; Contains: 10665973028894; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201421

FDA Product Code

• FXX: Mask, surgical

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: 2022-04-07
• Device Publish Date: 2022-03-30

On-Brand Devices [Dukal]

• 00665973015644: DK Vag Spec Lg.
• 00665973015637: DK Vag Spec Med
• 00665973015620: DK Vag Spec Sm.
• 10665973006748: DK Surgical Drape 18x26, ST
• 20665973006738: DK Fen Surg Drape 18x26, ST
• 20665973006431: DK Trach Care Kit, ST
• 20665973000521: DK OR TowelCSR WrapSoftpack,ST16"x26"Blue
• 20665973000491: DK OR Towel,CSR Wrap,Softpack,ST 16"x26",Blue
• 20665973000460: DK OR Towel,CSR Wrap,Softpack,ST 16"x26",Blue
• 00665973000459: DK OR TowelCSR WrapSoftpack,ST16"x26"Green
• 20665973000446: DK OR TowelCSR WrapSoftpack,ST16"x26"White
• 00665973000435: DK OR TowelCSR WrapSoftpack,ST16"x26"Blue
• 00665973000428: DK OR TowelCSR WrapSoftpack,ST16"x26"Green
• 20665973000408: DK OR TowelCSR WrapSoftpack,ST16"x26"Blue
• 20665973000378: OR Towel Sterile
• 20665973015761: DK OR TowelBulkNS16"x26", blue
• 20665973008640: DK OR Towel Pre Treat Green,16" x 26" NS 400/cs
• 20665973006561: DK OR Towel Pre Treat,BulkNS16"x26"Blue400
• 10665973005772: DK N95 Mask Cone w/ 1way valve
• 10665973005598: DK N95 Mask, Cone, White
• 10665973005574: DK N95 Mask Folded White NS
• 20665973005564: DK Surgical Mask w/earloopYellow NS
• 20665973005557: DK Surgical Mask w/ear loopBlueNS
• 20665973004994: DK Surgical Mask w/fluid,shield BL NS
• 20665973004987: DK Anti-Fog Surgical Mask,w/tie BL NS
• 20665973004970: DK Surgical Mask w/tie BL NS
• 10665973004966: DK Procedure Mask w/ear loop YEL NS
• 10665973004959: DK Procedure Mask w/ear loop BL NS
• 60665973010375: Level 2 Face Mask with Earloop BLUE
• 20665973028099: Sterile Antimicrobial Bandage Roll 4"x4.1yd
• 00665973027173: Sterilization Pouches, 3.5" x 10", NS
• 20665973028891: Surgical Mask, Level 2, Blue Earloop, NS
• 20665973027207: 27307
• 20665973027191: Sterilization Pouch, 5.25" x 10" NS
• 20665973027184: Sterilization Pouch, 3.5" x 10" NS
• 20665973027177: Sterilization Pouch, 3.5" x 10" NS
• 20665973027160: Sterilization Pouch, 3.5" x 5.25" NS
• 20665973027153: Sterilization Pouch, 2.75" x 10" NS
• 20665973027146: Sterilization Pouch, 2.25" x 4" NS