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: 00884450298824 FDA UDI

Identifiers

Catalog Number: OSC-6F-7S/B FDA UDI
Primary DI / UDI-DI: 00884450298824 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

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Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Closed-wound/centesis drainage receptacle

The One-Step catheter system is a single-use, closed-wound drainage receptacle designed for use in various medical procedures. It features a unique catheter tip configuration and is intended for the collection of cerebrospinal fluid (CSF) or blood. The device has undergone rigorous testing to ensure its safety and efficacy. One-Step stands out from other similar products due to its innovative design, high-quality materials, and compliant regulatory status.

Similar devices

Also classified as Closed-wound/centesis drainage receptacle.

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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

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Manufacturer

Manufacturer: Merit Medical Systems, Inc.

Sources (1)

FDA UDI dc123c20-69a9-4c16-a62b-a47d6245c25f 34 fields · synced Oct 7, 2026