Identity
- Trade Name
- Silicone Reservoir 200 ml FDA UDI
- Generic Name
- Closed-wound/centesis drainage receptacle FDA UDI
- Device Name
- The drainage system is composed of a silicone reservoir equipped with an anti-backflow valve and one or two connectors for connection to the drainage tube. The reservoir has a capacity of 200 ml. Thanks to the typical elasticity of silicone, the drainage suction power remains constant until the reservoir is completely full. FDA UDI
- Model / Reference
- 10410 FDA UDI
- Description
- The drainage system is composed of a silicone reservoir equipped with an anti-backflow valve and one or two connectors for connection to the drainage tube. The reservoir has a capacity of 200 ml. Thanks to the typical elasticity of silicone, the drainage suction power remains constant until the reservoir is completely full. FDA UDI
Identifiers
- Catalog Number
- 10410 FDA UDI
- Primary DI / UDI-DI
- 08034139290638 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
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: Closed-wound/centesis drainage receptacle
Silicone Reservoir 200 ml by Redax Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Closed-wound/centesis drainage receptacle.
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- Thoracentesis and Paracentesis Set — Merit Medical Systems, Inc. · Class I
- 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 (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
- Redax Spa
Sources (1)
- FDA UDI 52c37430-6d85-41a1-bf6f-792804918077 36 fields · synced May 30, 2026