Identity
- Trade Name
- Merit® Manifold FDA UDI
- Generic Name
- Stopcock FDA UDI
- Model / Reference
- 00884450023129 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884450023129 FDA UDI
- FDA Product Code
- DTL FDA UDI
- GMDN Term
- Stopcock FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4290 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
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: Stopcock
The Merit Manifold is a general-purpose valve used for regulating the direction of liquid or gas flow in various medical procedures. It is designed to be single-use and has been certified for use in cardiopulmonary bypass, a life-supporting procedure that requires precise control over blood flow.
Similar devices
Also classified as Stopcock.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 305b6dc4-88dd-48fe-9634-b5c4a924fa75 33 fields · synced Jul 25, 2026