FDA UDI
In Commercial Distribution
🇺🇸 United States
AngioTouch® Kit
DI: 10841716102001
·
Model: 014645
·
ACIST MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AngioTouch® Kit
- Primary DI
- 10841716102001
- Version / Model
- 014645
- Company Name
- ACIST MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 926684994
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-06
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 5e26410d-d4b2-48af-9c4c-9d1385b95ea3
Device Description
Model AT P65, p/n 701677-001 Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 47260 | Contrast medium injection system hand controller kit | A collection of non-powered devices designed to be used and interact with a contrast medium injection system for the administration of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of a high pressure line, a high pressure stopcock, and a hand-held manual controller used to stop and start the contrast medium injection system instantaneously. It is typically made of plastic materials and may have one control for dispensing the contrast medium and a second for dispensing the saline. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30841716102005 | GS1 | Shelf Box | 10 | In Commercial Distribution | |
| Primary | 10841716102001 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171646 | 000 |