Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Angiography kit FDA UDI
- Device Name
- CATH LAB PACK FDA UDI
- Model / Reference
- SAN69CLKM3 FDA UDI
- Description
- CATH LAB PACK FDA UDI
Identifiers
- Catalog Number
- SAN69CLKM3 FDA UDI
- Primary DI / UDI-DI
- 10888439671520 FDA UDI
- FDA Product Code
- OEQ FDA UDI
- GMDN Term
- Angiography kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Angiography kit
Cardinal Health's CATH LAB PACK is a comprehensive solution for cardiovascular procedures, providing a sterile and disposable angiography kit for preparing patients for vascular injections. This single-use device features a combination of fluid/contrast media administration and dedicated angiography supportive devices, ensuring a safe and accurate procedure. With its implantable status and active commercial distribution, this product is available for purchase in various quantities.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI 06c17479-b2a4-4a16-a27d-8eb451378745 34 fields · synced Jul 20, 2026