Identity
- Trade Name
- One-Vac™ EUDAMEDFDA UDI
- Generic Name
- Closed-wound/centesis drainage receptacle FDA UDI
- Device Name
- One-Vac Evacuated Drainage Bottle EUDAMED
- Model / Reference
- EVAC1000 EUDAMED00884450749609 FDA UDI00884450534113 FDA UDI
Identifiers
- Catalog Number
- EVAC1000/A FDA UDIEVAC1000 FDA UDI
- Primary DI / UDI-DI
- 00884450749609 EUDAMEDFDA UDI00884450534113 FDA UDI
- Basic UDI-DI
- 088445048816E4 EUDAMED
- FDA Product Code
- KDQ FDA UDI
- EMDN Code
- A06030401 INTRAOPERATIVE SUCTION CONTAINERS EUDAMED
- GMDN Term
- Closed-wound/centesis drainage receptacle FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDIFDA 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 UDIFDA UDI
Category: Closed-wound/centesis drainage receptacle
One-Vac™ by Merit Medical Systems, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (3)
- FDA UDI 349efad6-94a3-4bac-948f-1e8803539fc7 33 fields · synced Oct 8, 2026
- FDA UDI f5cd84bd-0804-42d1-8e00-2b07959133f6 33 fields · synced May 30, 2026
- EUDAMED 60d3c19a-cd35-4288-867b-e0dbbdeb6bf6 61 fields · synced Oct 8, 2026