FDA UDI
In Commercial Distribution
🇺🇸 United States
ACIST CVi® Contrast Delivery System Injector Head
DI: 10841716101875
·
Model: 016224
·
ACIST MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACIST CVi® Contrast Delivery System Injector Head
- Primary DI
- 10841716101875
- Version / Model
- 016224
- Company Name
- ACIST MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 926684994
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-13
- Public Version
- 1
- Public Version Date
- 2018-07-16
- Public Version Status
- New
- Public Device Record Key
- a412bd52-3e8c-4b23-9808-0186c92e5efb
Device Description
CVi Injector, p/n 700706-010
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57997 | Angiography contrast medium injection system, line-powered, mobile | An assembly of devices designed to inject contrast media through a small catheter and into the vascular system for angiographic procedures (e.g., examination of the coronary and renal arteries, and great vessels and vasculature of the heart, brain, abdominal organs, and extremities). It consists of mains electricity (AC-powered) electromechanical injectors (electric motor connected to a jackscrew that moves a syringe piston) with syringes capable of delivering media with the pressure, flow range, and volume required for angiographic studies, and is mobile (e.g., on a wheeled pedestal). Some types can synchronize media delivery with the electrocardiographic cycle and/or the x-ray generator. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841716101875 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171646 | 000 |