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IV ADMINISTRATION SET with Needleless Access Connector
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- IV ADMINISTRATION SET with Needleless Access Connector FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Model / Reference
- IV-013N FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00646311490101 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Basic intravenous administration set, noninvasive 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
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
IV ADMINISTRATION SET with Needleless Access Connector by Sb-Kawasumi Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID
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 d3d97ced-9451-4a9a-be16-a90d077fe087 34 fields · synced Jun 8, 2026