FDA UDI
In Commercial Distribution
🇺🇸 United States
Uni-Fuse+
DI: H787124018640
·
Model: 12401864
·
ANGIODYNAMICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Uni-Fuse+
- Primary DI
- H787124018640
- Version / Model
- 12401864
- Company Name
- ANGIODYNAMICS, INC.
- Labeler DUNS
- 079105071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-30
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 1e86317e-0a2b-45b3-a60d-885752600e50
Device Description
Uni-Fuse+ Infusion System 5F, 135cm, 15cm
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KRA | Catheter, continuous flush | Cardiovascular | 870.1210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32151 | Peripheral vascular intervention infusion catheter | A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | 15051684023955 | GS1 | ||||
| Primary | H787124018640 | HIBCC |
Customer Contacts
- Phone
- +1(518)795-1676
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202347 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 5 | French | |
| Outer Diameter | 1.71 | Millimeter | |
| Length | 135 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 27 Degrees Celsius