FDA UDI
In Commercial Distribution
🇺🇸 United States
AngioVac
DI: 15051684016490
·
Model: H965251930
·
Angiodynamics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- AngioVac
- Primary DI
- 15051684016490
- Version / Model
- H965251930
- Catalog Number
- 25193
- Company Name
- Angiodynamics, Inc.
- Labeler DUNS
- 079252781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-27
- Public Version
- 3
- Public Version Date
- 2025-12-05
- Public Version Status
- Update
- Public Device Record Key
- 7c0fb2b6-7830-42ce-bfb3-c1bc6c673de7
Device Description
AngioVac C20 with Obturator
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 |
|---|---|---|---|---|
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | Cardiovascular | 870.4210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34905 | Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage | A semi-rigid or rigid tube intended to be surgically inserted into the right atrium or large vein to serve as a channel for the extracorporeal transport of deoxygenated blood from a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as a venous cannula. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | H965251930 | HIBCC | ||||
| Primary | 15051684016490 | GS1 |
Customer Contacts
- Phone
- +1(800)772-6446
- [email protected]