Identity
- Trade Name
- PORT ACCESS INFUSION SET FDA UDI
- Generic Name
- Vascular port administration set FDA UDI
- Device Name
- Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through the Port Access Infusion Set are those generally used in hospitals, and for chemotherapy. FDA UDI
- Model / Reference
- PI03091 FDA UDI
- Description
- Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through the Port Access Infusion Set are those generally used in hospitals, and for chemotherapy. FDA UDI
Identifiers
- Catalog Number
- PI03091 FDA UDI
- Primary DI / UDI-DI
- 04987488102272 FDA UDI
- FDA Product Code
- FRN FDA UDI
- GMDN Term
- Vascular port administration set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 19 Gauge FDA UDI
Category: Vascular port administration set
Port Access Infusion Set by Sb-Kawasumi Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular port administration set.
- Port Access Needle — Bard Access Systems, Inc. · Class II
- VYGON — Vygon Corp. · Class II
- VYGON — Vygon Corp. · Class II
- Port Access Needle — Bard Access Systems, Inc. · Class II
- PowerLoc — Bard Access Systems, Inc. · Class II
- Port Access Kit — Bard Access Systems, Inc. · Class II
- Port Access Kit — Bard Access Systems, 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
- Sb-Kawasumi Laboratories, Inc.
Sources (1)
- FDA UDI 0d41aec3-80dc-47de-931d-efa4aeb6bf0b 36 fields · synced Jun 7, 2026