Identity
- Trade Name
- VASOSHIELD EUDAMEDFDA UDIVasoshield Pressure Controlling Syringe EUDAMED
- Generic Name
- Vascular irrigation cannula, cardiac vessel graft FDA UDI
- Device Name
- VASOSHIELD SYRINGE 50cc EUDAMEDVasoshield Pressure Controlling Syringe EUDAMEDFDA UDI
- Model / Reference
- VH-5001 EUDAMEDFDA UDI
- Description
- Vasoshield Pressure Controlling Syringe FDA UDI
Identifiers
- Catalog Number
- VH-5001 FDA UDI
- Primary DI / UDI-DI
- 00607567700468 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00607567700468 EUDAMED607567VH-5001TP EUDAMED
- FDA Product Code
- GBX FDA UDI
- EMDN Code
- A020102020102 INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMEDA02010299 INFUSION AND IRRIGATION SYRINGES - OTHER EUDAMED
- GMDN Term
- Vascular irrigation cannula, cardiac vessel graft FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Market of Registration
- Sweden EUDAMEDNetherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Vasoshield by Maquet Cardiovascular LLC — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00607567700468 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00607567700468 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- MAQUET Cardiovascular, LLC
- EUDAMED SRN
- US-MF-000011693
- Authorised Representative
- MAQUET Critical Care AB SE-AR-000001442
Sources (3)
- EUDAMED d895266e-a43f-4ef2-a43e-ce5fdc460671 61 fields · synced Jun 19, 2026
- FDA UDI d3327ffb-963a-45a3-b776-7a243224e697 35 fields · synced May 29, 2026
- EUDAMED 0ca8a377-bc3a-44a4-a475-76fe51ff1426 61 fields · synced Jun 19, 2026