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: 00884450048313 FDA UDI

Identifiers

Catalog Number: K10-02963 FDA UDI
Primary DI / UDI-DI: 00884450048313 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

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, one-time-use device designed to collect fluids or purulent material during drainage of the body cavity. This receptacle is typically packaged in single units and labeled as Universal Drainage Tray (PD), which contains fluid volume markers and may include a hand-operated pump (suction bulb) and tubing. The device meets FDA standards for sterility, safety, and efficacy.

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 5a1028a5-ffbb-4886-8318-e9209b9f5f8d 33 fields · synced Oct 6, 2026