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BAROVAC® Evacuator Closed Wound Drainage System(PP)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- BAROVAC® Evacuator Closed Wound Drainage System(PP) FDA UDI
- Generic Name
- Closed-wound drainage kit FDA UDI
- Device Name
- BAROVAC PP 400-3.2 FDA UDI
- Model / Reference
- PP400C(3.2) FDA UDI
- Description
- BAROVAC PP 400-3.2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806369498722 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Closed-wound drainage kit 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
Yes
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 drainage kit
BAROVAC® Evacuator Closed Wound Drainage System(PP) by Sewoon Medical Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Closed-wound drainage kit.
- Closed Wound Suction — C. R. Bard, Inc. · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Closed Wound Suction — C. R. Bard, Inc. · Class I
- AVID TruCustom — AVID MEDICAL, INC. · Class II
- Custom Healthcare Systems Inc. — Manus Medical, LLC · Class II
- SKATER™ Single Step Drainage Set — Argon Medical Devices, Inc. · Class I
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC · Class I
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
- Sewoon Medical Co., Ltd.
Sources (1)
- FDA UDI 30421b6a-b7f4-4b26-aed2-014915fd98c4 33 fields · synced May 30, 2026