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: 00884450298688 FDA UDI

Identifiers

Catalog Number: OSC-8F-7L/A FDA UDI
Primary DI / UDI-DI: 00884450298688 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

Yes

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™ by Merit Medical Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 3d424dd3-df15-4ef1-a0ee-1142b6b4b337 34 fields · synced Jun 9, 2026