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: 00884450189429 FDA UDI

Identifiers

Primary DI / UDI-DI: 00884450189429 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 procedural medication labeling set designed for perioperative and other procedural settings. This single-use device provides a standardized method to label medications, solutions, or other substances in sterile field, ensuring accurate and efficient workflow. Developed by Merit Medical Systems, Inc., this product is intended for use by medical professionals and offers features such as a permanent marking pen, various labels made of moisture-resistant plastic material, and text fields.

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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 29359199-b04f-42f9-b25f-13d5c6ad16c1 32 fields · synced Jul 17, 2026