NovoPen Echo® 185459

GUDID 30301691854592

NovoPen Echo® is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart injection], and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.

NOVO NORDISK INC.

Cartridge-accepting autoinjector, mechanical Cartridge-accepting autoinjector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical Empty self-injector, mechanical

• Primary Device ID: 30301691854592
• NIH Device Record Key: c1f2ce55-8d94-40ca-bdea-a4e2bde80b5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovoPen Echo®
• Version Model Number: 185459
• Catalog Number: 185459
• Company DUNS: 012177531
• Company Name: NOVO NORDISK INC.
• Device Count: 1
• 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: true
• Single Use: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com
• Phone: 1-800-727-6500
• Email: nnicustomercare@novonordisk.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00301691854591 [Primary]
GS1	30301691854592 [Package]; Contains: 00301691854591; Package: [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162602

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-03
• Device Publish Date: 2016-11-23

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