Identity
- Trade Name
- VYGON FDA UDI
- Generic Name
- Vascular port administration set FDA UDI
- Device Name
- Perfusafe2 + autoflush - Non-coring safety needle - Ø0.7mm (22G) - L.20mm ( in.) FDA UDI
- Model / Reference
- 5249.721 FDA UDI
- Description
- Perfusafe2 + autoflush - Non-coring safety needle - Ø0.7mm (22G) - L.20mm ( in.) FDA UDI
Identifiers
- Catalog Number
- 005249721 FDA UDI
- Primary DI / UDI-DI
- 03660812064880 FDA UDI
- FDA Product Code
- FPD FDA UDIKNT FDA UDI
- GMDN Term
- Vascular port administration set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular port administration set
Vygon by Vygon Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PORT ACCESS INFUSION SET — SB-KAWASUMI LABORATORIES, INC. · Class II
- Port Access Kit — Bard Access Systems, Inc. · Class II
- Infusion Safety Products, Inc. — Infusion Safety Products, Inc. · Class II
- Infusion Safety Products, Inc. — Infusion Safety Products, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vygon Corp.
Sources (1)
- FDA UDI eba5a0b1-a798-4647-9c66-d8e0cc3b0961 35 fields · synced May 30, 2026