Merit Medical®

FDA UDI

Class I (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: Merit Medical® FDA UDI
Generic Name: Procedural medication labelling set FDA UDI
Model / Reference: 00884450459263 FDA UDI

Identifiers

Primary DI / UDI-DI: 00884450459263 FDA UDI
FDA Product Code: PYB FDA UDI
GMDN Term: Procedural medication labelling set FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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: Procedural medication labelling set

Merit Medical's Minor Surgical Procedures Tray is a comprehensive labeling solution designed to provide clinical staff with a standardized method for labeling medications, medication containers, and other solutions in procedural settings. With its permanent marking pen and moisture-resistant labels, this device ensures accurate and efficient labeling, reducing the risk of errors and improving patient safety.

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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 519f53b8-e08f-462e-b706-a9200711c44c 32 fields · synced Jul 13, 2026