Identity
- Trade Name
- High Pressure Tubing FDA UDI
- Generic Name
- Radiographic procedure tubing FDA UDI
- Model / Reference
- 00884450334652 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884450334652 FDA UDI
- FDA Product Code
- FPK FDA UDI
- GMDN Term
- Radiographic procedure tubing 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
No
FDA UDI
Category: Radiographic procedure tubing
A flexible, cylindrical device made of synthetic polymers that connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids during diagnostic radiographic procedures.
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Also classified as Radiographic procedure tubing.
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- 10” (25 cm) High Pressure Connector Tube — Bayer Medical Care 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
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 959b4365-cd26-4462-9aa1-ce61a26e09c3 33 fields · synced Jul 10, 2026