FDA UDI
In Commercial Distribution
🇺🇸 United States
JetfallAngio
DI: 06973364962892
·
Model: AMTY-EU001
·
AMT Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- JetfallAngio
- Primary DI
- 06973364962892
- Version / Model
- AMTY-EU001
- Company Name
- AMT Medical Inc.
- Labeler DUNS
- 543436397
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-30
- Public Version
- 2
- Public Version Date
- 2026-04-17
- Public Version Status
- Update
- Public Device Record Key
- edd47cbe-71d8-4e94-a35b-3cbd00d680bb
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40721 | Manual contrast medium injection system | An assembly of devices designed for the manual-only injection of contrast media into the blood or lymphatic vessels of a patient for a diagnostic imaging procedure; it enables the operator to manually control the volume and rate of contrast media administered under pressure. The system typically consists of a graduated injection syringe, a manifold with multiple stopcocks, and a pressure transducer system used by the operator to monitor catheter-tip pressure. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06973364962892 | GS1 |