Identity
- Trade Name
- PeriVac™ Kit FDA UDI
- Generic Name
- Pericardiocentesis catheter FDA UDI
- Model / Reference
- 00884450486115 FDA UDI
Identifiers
- Catalog Number
- M004PERIVAC1S0 FDA UDI
- Primary DI / UDI-DI
- 00884450486115 FDA UDI
- FDA Product Code
- PXU FDA UDI
- GMDN Term
- Pericardiocentesis catheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
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
No
FDA UDI
Category: Pericardiocentesis catheter
A comprehensive PeriVac Kit for the safe and effective drainage of pericardial effusions, providing a flexible tube design for pericardiocentesis.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 546d73d3-e4b3-400d-9d67-ef67ad039d4d 33 fields · synced Jul 20, 2026