Merit Medical®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: Merit Medical® FDA UDI
Generic Name: Closed-wound/centesis drainage receptacle FDA UDI
Model / Reference: 00884450396186 FDA UDI

Identifiers

Primary DI / UDI-DI: 00884450396186 FDA UDI
FDA Product Code: PPD FDA UDI
GMDN Term: Closed-wound/centesis drainage receptacle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5130 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

Yes

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

Merit Medical's Closed-wound/centesis drainage receptacle is a sterile container designed to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct. It is typically in the form of a bottle, bag, or bulb with fluid volume markers and does not include invasive components or powered devices. This single-use device is intended for use by healthcare professionals in gynecology, urology, and gastroenterology.

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 II	Pending data

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Manufacturer

Manufacturer: Merit Medical Systems, Inc.

Sources (1)

FDA UDI 44f44e09-8872-42b3-8c65-72223f2a4d2f 32 fields · synced Oct 6, 2026