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Merit® Kit

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Merit® Kit FDA UDI
Generic Name
Peritoneal dialysis catheter introduction set FDA UDI
Model / Reference
00884450328613 FDA UDI

Identifiers

Catalog Number
K14-00078 FDA UDI
Primary DI / UDI-DI
00884450328613 FDA UDI
FDA Product Code
PEV FDA UDI
GMDN Term
Peritoneal dialysis catheter introduction set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5820 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: Peritoneal dialysis catheter introduction set

The Merit Kit is a comprehensive peritoneal dialysis catheter introduction set designed for single-use use. This kit includes all necessary components for safe and effective initiation of peritoneal dialysis, making it an ideal choice for patients requiring this type of treatment.

Similar devices

Also classified as Peritoneal dialysis catheter introduction set.

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 d3c01125-5eb3-45aa-9c96-447b91a08c12 34 fields · synced Jul 15, 2026