FDA.reportPublic FDA data

ZOMA-Jet

Primary DI
07640180261018
Brand
ZOMA-Jet
Company
FERRING PHARMACEUTICALS INC.
Model
10mg Demonstration Kit
Catalog number
55566-1903-1
Device description
Needle-free delivery device for use with ZOMACTON (somatropin) for Injection 10mg vial, 7 Head A's, Carry Case and User Manual.
Published
2018-08-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZEInjector, Fluid, Non-Electrically Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZEInjector, Fluid, Non-Electrically PoweredGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991294000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991294000MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEMMedi-Ject Corp.1999-04-23KZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640180261018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640180261018076401802610187640180261018

GMDN Terms#

Term, Definition table
TermDefinition
Medication cartridge syringe, needleless, reusableA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888) 337-7464MedqueriesUS@ferring.com

Regulatory Flags#

DUNS number
103722955
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640128544210Euflexxa41002014-09-24
07640180262657Rebyota 55566-9850-12023-02-24
07640180261001ZOMA-Jet5mg Demonstration Kit55566-1803-12018-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199284222250Robbins Dermo-jetRobbins Instruments Inc.KZE2025-08-22
07290016746754Treatment Kit 2.0VIORA LTDKZE2025-06-03
07290016746761Treatment Kit 2.0VIORA LTDKZE2025-06-03
07290016746716ConsoleVIORA LTDKZE2025-05-22
07290016746723ApplicatorVIORA LTDKZE2025-05-22
07290016746730TrolleyVIORA LTDKZE2025-05-22
07290016746747Disposable Delivery NozzleVIORA LTDKZE2025-05-22
B07281641001J-TipNATIONAL MEDICAL PRODUCTS, INC.KZE2024-05-27
B07281642001J-TipNATIONAL MEDICAL PRODUCTS, INC.KZE2024-05-27
07290017151007AirGent-2.0PERFACTION TECHNOLOGIES LTDKZE2018-12-18
07640180261001ZOMA-JetFERRING PHARMACEUTICALS INC.KZE2018-08-01
00856457003329Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003336Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003206Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003213Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003305Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003312Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003367Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003374Stratis®PHARMAJET, INC.KZE2016-09-19