Identity
- Trade Name
- Typenex Wound Drainage FDA UDI
- Generic Name
- Closed-wound drainage kit FDA UDI
- Device Name
- Kit with 400 ml Spring Reservoir and 10 FR Perforated Round, with Trocar FDA UDI
- Model / Reference
- WD0702TK5 FDA UDI
- Description
- Kit with 400 ml Spring Reservoir and 10 FR Perforated Round, with Trocar FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812269031325 FDA UDI
- FDA Product Code
- KGZ FDA UDI
- GMDN Term
- Closed-wound drainage kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Closed-wound drainage kit
Typenex Wound Drainage by Typenex Medical, LLC — 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
- BAROVAC® Evacuator Closed Wound Drainage System(SS) — Sewoon Medical Co., Ltd. · 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
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
- Typenex Medical, LLC
Sources (1)
- FDA UDI ffd37b5b-10b2-460f-ba14-6899765f0333 33 fields · synced Jun 1, 2026