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: 00884450319659 FDA UDI

Identifiers

Catalog Number: K10T-04942A FDA UDI
Primary DI / UDI-DI: 00884450319659 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 Universal Drainage Tray is a sterile, single-use closed-wound/centesis drainage receptacle designed for use in gynecology and urology procedures. This device features a hand-operated pump (suction bulb) and fluid volume markers, making it easy to collect and drain fluids or purulent material from body cavities, wounds, or bile ducts.

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 II	Pending data

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

Manufacturer

Manufacturer: Merit Medical Systems, Inc.

Sources (1)

FDA UDI 08808807-bfdf-473b-b285-21d43ac912a4 33 fields · synced Oct 6, 2026