One-Step™

FDA UDI

Class I (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: One-Step™ FDA UDI
Generic Name: Closed-wound/centesis drainage receptacle FDA UDI
Model / Reference: 00884450387597 FDA UDI

Identifiers

Catalog Number: OSC-8F-17PL/B FDA UDI
Primary DI / UDI-DI: 00884450387597 FDA UDI
FDA Product Code: GBX FDA UDI
GMDN Term: Closed-wound/centesis drainage receptacle 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Closed-wound/centesis drainage receptacle

One-Step is a revolutionary closed-wound/centesis drainage receptacle designed to simplify catheter-based fluid management. This single-use device features a sterile container that connects to an invasive drain/drainage catheter, allowing for the collection of fluids or purulent material from various body cavities. With its hand-operated pump and tubing included, One-Step enables users to perform complex drainage procedures with precision and efficiency.

Similar devices

Also classified as Closed-wound/centesis drainage receptacle.

Jet-Vac — PFM MEDICAL INCORPORATED · Class II
Silicone C.W.V. Reservoir — FORTUNE MEDICAL INSTRUMENT CORP. · Class I
400 ml SeromaSet (US) — Innoventa Medica ApS
Porges Coloplast — Coloplast A/S · Class I
AWI — Apex (Guangzhou) Tools & Orthopedics Co. · Class I
Tru-Close Suction Drainage System — Uresil Corp. · Class I
Tru-Close Suction Drainage System — Uresil Corp. · Class I
AWI — Apex (Guangzhou) Tools & Orthopedics Co. · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Merit Medical Systems, Inc.

Sources (1)

FDA UDI 471e38b1-c5fc-46f4-8e9c-b8e42293284b 34 fields · synced Oct 6, 2026