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Device Explorer · FDA GUDID · GMDN 11305

Closed-wound drain, non-bioabsorbable

A tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lum

US‑registered devices1,028in commercial distribution
Companies27labelers on GUDID
Single‑use100%of device records
Sterile97%labelled sterile
Prescription63%Rx‑only share
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Share of device records

Merit Medical Systems, Inc.24023%
Cardinal Health 200, Llc12913%
Fortune Medical Instrument Corp.11511%
Axiom Medical, Incorporated697%
C. R. Bard, Inc.677%
Redax Spa616%
Argon Medical Devices, Inc.596%
Aspen Surgical Products, Inc.475%

Top labelers

CompanyDevicesShare
Merit Medical Systems, Inc.24023%
Cardinal Health 200, Llc12913%
Fortune Medical Instrument Corp.11511%
Axiom Medical, Incorporated697%
C. R. Bard, Inc.677%
Redax Spa616%
Argon Medical Devices, Inc.596%
Aspen Surgical Products, Inc.475%
Typenex Medical Llc434%
Navilyst Medical, Inc.273%
Armm Inc.263%
Cook Incorporated252%

Company = labeler of record on GUDID. 27 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Wellead EvacuatorComfort DrainTypenex Wound DrainageAspen® Y AdapterSKATER™ Mini-Loop Drainage SetSkater™ All-Purpose and Nephrostomy SetSkater™ All Purpose and Nephrostomy Drainage SetSkater™ All Purpose and Nephrostomy DrainageSkater™ All-Purpose and Nephrostomy Drainage SetSKATER™ Drainage CatheterJACKSON-PRATTReSolve®ReSolve®, StayFIX®ReSolve Mini™One-Step™Cen-Step™

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
GBXCATHETER, IRRIGATION521
GCDConnector, Catheter115
GBXCatheter, Irrigation92
KGZAccessories, Catheter90
GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED59
JOLCATHETER AND TIP, SUCTION44

GMDN & GCC registration

  • GMDN code 11305 · non‑implantable
  • Single‑use 100% · sterile 97% · Rx‑only 63% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Catheter Gauge (French) · 239Length (Centimeter) · 117Length (Inch) · 64Outer Diameter (Millimeter) · 41Total Volume (Milliliter) · 18Outer Diameter (Inch) · 13

Use these as the dimensions to specify in a tender line.

How many closed-wound drain, non-bioabsorbable products are registered in the US?

1,028 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Closed-wound drain, non-bioabsorbable", from 27 companies. The largest labeler is Merit Medical Systems, Inc. with 23% of records.

Which FDA product codes apply?

GBX (CATHETER, IRRIGATION), GCD (Connector, Catheter), GBX (Catheter, Irrigation), KGZ (Accessories, Catheter)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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