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: 00884450189603 FDA UDI

Identifiers

Catalog Number: K13-01137 FDA UDI
Primary DI / UDI-DI: 00884450189603 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

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 proprietary procedural medication labeling set is designed to provide a standardized method for labeling medications, medication containers, and other solutions in and outside the sterile field. With its permanent marking pen and various moisture-resistant labels, this single-use device is ideal for minor surgical procedures and other perioperative settings.

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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 8139d5d5-5edc-4ee5-8f74-7bfa35729af0 33 fields · synced Jul 17, 2026