FDA UDI
In Commercial Distribution
🇺🇸 United States
AngioDynamics
DI: 15051684011716
·
Model: H787065200010
·
Angiodynamics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- AngioDynamics
- Primary DI
- 15051684011716
- Version / Model
- H787065200010
- Catalog Number
- 06520001
- Company Name
- Angiodynamics, Inc.
- Labeler DUNS
- 079252781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-14
- Public Version
- 1
- Public Version Date
- 2025-11-24
- Public Version Status
- New
- Public Device Record Key
- c23e86a9-7d9c-4d30-b99d-419a7cc9f39e
Device Description
Straight, Non-Coring, High-Flow Needle
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 |
|---|---|---|---|---|
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17701 | Vascular port administration set | A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 25051684011713 | GS1 | BX | 10 | In Commercial Distribution | |
| Primary | 15051684011716 | GS1 | ||||
| Previous | H787065200010 | HIBCC |
Customer Contacts
- Phone
- +1(800)772-6446
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013871 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 27 Degrees Celsius