ZOMA-Jet 55566-1803-1

GUDID 07640180261001

Needle-fre4e delivery device for use with ZOMACTON (somatropin) for Injection 5mg vial, 5 Head A's, Carry Case and User Manual.

FERRING PHARMACEUTICALS INC.

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• Primary Device ID: 07640180261001
• NIH Device Record Key: bfe44b6e-1947-45ca-83eb-e2d428c613ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOMA-Jet
• Version Model Number: 5mg Demonstration Kit
• Catalog Number: 55566-1803-1
• Company DUNS: 103722955
• Company Name: FERRING PHARMACEUTICALS 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: true
• 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(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com
• Phone: +1(888) 337-7464
• Email: MedqueriesUS@ferring.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640180261001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991294

FDA Product Code

• KZE: Injector, Fluid, Non-Electrically Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-22
• Device Publish Date: 2018-08-01

On-Brand Devices [ZOMA-Jet]

• 07640180261001: Needle-fre4e delivery device for use with ZOMACTON (somatropin) for Injection 5mg vial, 5 Head A
• 07640180261018: Needle-free delivery device for use with ZOMACTON (somatropin) for Injection 10mg vial, 7 Head A