ZOMA-Jet

Basic Information

• Brand Name: ZOMA-Jet
• Primary DI: 07640180261001
• Version / Model: 5mg Demonstration Kit
• Catalog Number: 55566-1803-1
• Company Name: FERRING PHARMACEUTICALS INC.
• Labeler DUNS: 103722955
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-01
• Public Version: 4
• Public Version Date: 2021-08-19
• Public Version Status: Update
• Public Device Record Key: bfe44b6e-1947-45ca-83eb-e2d428c613ee
• Distribution End Date: 2021-06-30

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KZE	Injector, Fluid, Non-Electrically Powered	General Hospital	880.5430	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63446	Medication cartridge syringe, needleless, reusable	A sterile device designed to be used in conjunction with a hermetically-sealed glass cartridge containing medication (not included) to propel the contents of the cartridge across the skin (transcutaneous delivery) and into the subcutaneous tissue (needleless) when used in combination with an injector (not included). It consists of a breech-loading barrel, plunger and specialized nozzle. This is a single-patient reusable device.	No	Active
60539	Vial/bottle adaptor, non-hermetic	A device intended to be fitted to a vial or bottle to enable the removal of its contents, (e.g., medication, nutritional solution for enteral feeding) into a syringe, for subsequent administration to a patient. It is typically a housing with a barbed connection or spike that attaches to or replaces the container lid, and a small bore connection (typically ENFit or a Luer); it does not allow for pressure equalization/airtight transfer of contents. This is a single-use device.	No	Active
18069	Needleless medication/vaccine injector, mechanical	A hand-held, mechanically-powered (e.g., spring-powered) device designed to inject medication (especially a local anaesthetic, vaccine or medication) transcutaneously into the human body. It is a manually-operated, needleless device that can have various configurations according to application. It will typically be a pistol-shaped plunger driven instrument with single or multi-pointed holed barrels through which the medication/vaccine is driven under high pressure. The delivered medication/vaccine will typically be supplied in prefilled containers. This device is not a hypodermic syringe. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640180261001	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K991294	000