Identity
- Trade Name
- Silicone C.W.V. Reservoir (Top Outlet) FDA UDI
- Generic Name
- Closed-wound/centesis drainage receptacle FDA UDI
- Model / Reference
- 2013-1640 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14710961934872 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Closed-wound/centesis drainage receptacle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4680 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
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
Yes
FDA UDI
Category: Closed-wound/centesis drainage receptacle
Silicone C.W.V. Reservoir (Top Outlet) by Fortune Medical Instrument Corp. — Class I — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Closed-wound/centesis drainage receptacle.
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- One-Step™ — Merit Medical Systems, Inc. · Class I
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
Sources (2)
- FDA UDI 369f9537-cb1e-4678-8c5c-acc7c698da43 32 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 18, 2026