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IV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access Connec
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- IV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access Connec FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Model / Reference
- IV-027N FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00646311490224 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
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
IV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access Connec 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 4de6ed01-5a85-4ed6-a31a-b2622130b391 33 fields · synced May 30, 2026