Identity
- Trade Name
- Box - 600 ml. SeromaSet FDA UDI
- Generic Name
- Closed-wound/centesis drainage receptacle FDA UDI
- Device Name
- A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device. FDA UDI
- Model / Reference
- 1061 FDA UDI
- Description
- A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700002169747 FDA UDI
- GMDN Term
- Closed-wound/centesis drainage receptacle FDA UDI
Classification
- 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
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
Category: Closed-wound/centesis drainage receptacle
Box - 600 ml. SeromaSet by Innoventa Medica ApS — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Closed-wound/centesis drainage receptacle.
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- One-Step™ — Merit Medical Systems, Inc. · Class I
- 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Innoventa Medica ApS
Sources (1)
- FDA UDI f3277908-b4cf-41e8-932c-49d084619930 33 fields · synced Jun 6, 2026