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Merit Medical®

FDA UDI

Class I (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Merit Medical® FDA UDI
Generic Name
Pericardiocentesis catheter FDA UDI
Model / Reference
00884450015278 FDA UDI

Identifiers

Catalog Number
PC101/B FDA UDI
Primary DI / UDI-DI
00884450015278 FDA UDI
FDA Product Code
GBX FDA UDI
GMDN Term
Pericardiocentesis catheter FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pericardiocentesis catheter

A flexible tube designed for the drainage of effusion from the pericardial sac, typically consisting of a thin-walled, flexible plastic tube with multiple perforations. This medical device is used for irrigation and instillation of drugs into the pericardium during cardiac tamponade treatment.

Similar devices

Also classified as Pericardiocentesis catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI 9cb6bc9e-2f89-47cb-b9a7-e95a263eaee7 33 fields · synced Jul 24, 2026