Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Closed-wound drain, non-bioabsorbable FDA UDI
- Device Name
- DRAIN JACKSON-PRT 10FR W/TROC FDA UDI
- Model / Reference
- SU130-0521 FDA UDI
- Description
- DRAIN JACKSON-PRT 10FR W/TROC FDA UDI
Identifiers
- Catalog Number
- SU130-0521 FDA UDI
- Primary DI / UDI-DI
- 10885380103063 FDA UDI
- FDA Product Code
- GBX FDA UDI
- GMDN Term
- Closed-wound drain, non-bioabsorbable 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Closed-wound drain, non-bioabsorbable
Cardinal Health's CATHETER, Irrigation (device code: GBX) is a non-bioabsorbable tube-like device designed to establish a channel for the removal of fluid or purulent material from closed-wound or infected areas. Typically used with a closed drainage system that applies low negative pressure through the drain lumen.
Similar devices
Also classified as Closed-wound drain, non-bioabsorbable.
- ReSolve® — Merit Medical Systems, Inc. · Class I
- One-Step™ — Merit Medical Systems, Inc. · Class I
- Silicone Vac Drain, Round — FORTUNE MEDICAL INSTRUMENT CORP. · Class IIa
- SKATER™ Mini-Loop Drainage Set — Argon Medical Devices, Inc. · Class I
- Drainage Tube and Accessories — Hangzhou Fushan Medical Appliances Co., Ltd. · Class IIa
- Exodus — NAVILYST MEDICAL, INC. · Class II
- One-Step™ — Merit Medical Systems, Inc. · Class I
- Aspen® Discrete Drain — Aspen Surgical Products, 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
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI f1188be0-1ddc-4a60-9875-76bcf548f562 34 fields · synced Jul 29, 2026