Identity
- Trade Name
- K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET FDA UDI
- Generic Name
- Vascular port administration set FDA UDI
- Model / Reference
- PA03091 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00646311552939 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
- Not 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
K-Shield Advantage Port Access Infusion Set by Sb-Kawasumi Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 d6053310-57e7-45d7-a7c1-a75e4b0a1a6d 33 fields · synced Jun 1, 2026