FDA UDI
In Commercial Distribution
🇺🇸 United States
Stratis®
DI: 00856457003213
·
Model: C501-20
·
PHARMAJET, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Stratis®
- Primary DI
- 00856457003213
- Version / Model
- C501-20
- Catalog Number
- C501-20
- Company Name
- PHARMAJET, INC.
- Labeler DUNS
- 609816892
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 2f422978-5442-47b8-a401-04949a0fc0fc
Device Description
0.5mL Stratis® Reset Station
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 45449 | Injector reset device | A device designed to be used by a layperson (this usually being the recipient of the injection) to reset the loaded position of an injector in a safe and controlled manner. It will typically be designed like a small box or container and have a hinged lid. The injector is placed inside this device and when the lid is closed an internal mechanism resets the injector to its firing position. The injector is removed from this device, the medication is inserted (typically a prefilled syringe or cartridge) and it is ready for use by the user. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856457003213 | GS1 | ||||
| Package | 10856457003210 | GS1 | Case | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111517 | 000 |