FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ZOMA-Jet
DI: 07640180261018
·
Model: 10mg Demonstration Kit
·
FERRING PHARMACEUTICALS INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZOMA-Jet
- Primary DI
- 07640180261018
- Version / Model
- 10mg Demonstration Kit
- Catalog Number
- 55566-1903-1
- 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
- 2
- Public Version Date
- 2021-08-19
- Public Version Status
- Update
- Public Device Record Key
- 382e2321-ca81-45c3-a349-448eb5da4940
- Distribution End Date
- 2021-06-30
Device Description
Needle-free delivery device for use with ZOMACTON (somatropin) for Injection 10mg vial, 7 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 |
| 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 | 07640180261018 | GS1 |
Customer Contacts
- Phone
- +1(888) 337-7464
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991294 | 000 |