Identity
- Trade Name
- VANGUARD FDA UDI
- Generic Name
- Cardioplegia solution administration kit FDA UDI
- Model / Reference
- D924P BLOOD DELIVERY SET 4:1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033178250610 FDA UDI
- 510(k) Number
- K934847 FDA UDI
- FDA Product Code
- DTN FDA UDI
- GMDN Term
- Cardioplegia solution administration kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4400 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: Cardioplegia solution administration kit
Vanguard by Sorin Group Italia Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardioplegia solution administration kit.
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- MPS 3 ND Delivery Set w/AA w/183 Line (16C) — QUEST MEDICAL INC · Class II
Cleared under the same submission
K934847 also covers:
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
- Sorin Group Italia Srl
Sources (1)
- FDA UDI b6c06030-8188-421b-9b52-70064b2d361e 33 fields · synced Jun 6, 2026