ZOMA-Jet 55566-1903-1

GUDID 07640180261018

Needle-free delivery device for use with ZOMACTON (somatropin) for Injection 10mg vial, 7 Head A's, Carry Case and User Manual.

FERRING PHARMACEUTICALS INC.

Medication cartridge syringe, needleless, reusable
Primary Device ID07640180261018
NIH Device Record Key382e2321-ca81-45c3-a349-448eb5da4940
Commercial Distribution Discontinuation2021-06-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameZOMA-Jet
Version Model Number10mg Demonstration Kit
Catalog Number55566-1903-1
Company DUNS103722955
Company NameFERRING PHARMACEUTICALS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888) 337-7464
EmailMedqueriesUS@ferring.com
Phone+1(888) 337-7464
EmailMedqueriesUS@ferring.com
Phone+1(888) 337-7464
EmailMedqueriesUS@ferring.com
Phone+1(888) 337-7464
EmailMedqueriesUS@ferring.com
Phone+1(888) 337-7464
EmailMedqueriesUS@ferring.com
Phone+1(888) 337-7464
EmailMedqueriesUS@ferring.com
Phone+1(888) 337-7464
EmailMedqueriesUS@ferring.com
Phone+1(888) 337-7464
EmailMedqueriesUS@ferring.com
Phone+1(888) 337-7464
EmailMedqueriesUS@ferring.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107640180261018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KZEInjector, Fluid, Non-Electrically Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-08-19
Device Publish Date2018-08-01

On-Brand Devices [ZOMA-Jet]

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

Trademark Results [ZOMA-Jet]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZOMA-JET
ZOMA-JET
86607873 4994505 Live/Registered
Ferring B.V.
2015-04-23

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