FDA UDI
In Commercial Distribution
🇺🇸 United States
A2000 Multi-use Syringe Kit
DI: 10841716102544
·
Model: 014612
·
ACIST MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- A2000 Multi-use Syringe Kit
- Primary DI
- 10841716102544
- Version / Model
- 014612
- Company Name
- ACIST MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 926684994
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-06
- Public Version
- 1
- Public Version Date
- 2020-11-16
- Public Version Status
- New
- Public Device Record Key
- 1ab057f9-dcca-41f3-8aba-912d29700f24
Device Description
A2000 Multi-use Syringe Kit, p/n 701669-008 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp with disinfecting caps
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47259 | Contrast medium injection system syringe | A component of a contrast medium injection system for the administration of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It is primarily an exchangeable plunger-in-barrel chamber for the medium/solution; the movement of the plunger (piston) is controlled by the contrast medium/solution injector. It is typically made of plastic materials and can be reused for several patients, e.g., up to five patients. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30841716102548 | GS1 | Shelf Box | 10 | In Commercial Distribution | |
| Primary | 10841716102544 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171646 | 000 |