Identity
- Trade Name
- K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET FDA UDI
- Generic Name
- Vascular port administration set FDA UDI
- Device Name
- The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to surgically implanted port. FDA UDI
- Model / Reference
- PA03090 FDA UDI
- Description
- The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to surgically implanted port. FDA UDI
Identifiers
- Catalog Number
- PA03090 FDA UDI
- Primary DI / UDI-DI
- 00646311553080 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Vascular port administration set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
K-Shield Advantage 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 c2a87fb5-c70c-49c4-82a9-fbcbcb5f2863 36 fields · synced Jun 8, 2026