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Merit Medical®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Merit Medical® FDA UDI
Generic Name
Invasive blood pressure transducer set FDA UDI
Model / Reference
00884450159279 FDA UDI

Identifiers

Catalog Number
K11-01040 FDA UDI
Primary DI / UDI-DI
00884450159279 FDA UDI
FDA Product Code
OEZ FDA UDI
GMDN Term
Invasive blood pressure transducer set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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: Invasive blood pressure transducer set

Merit Medical's Invasive Blood Pressure Transducer Set is a comprehensive, single-use solution for precise and accurate blood pressure measurement. This set includes a sterile, invasive catheter with a built-in pressure transducer, allowing for real-time monitoring of pulse pressure and cardiac output. The device is designed for implantable use in patients requiring continuous blood pressure monitoring. With its advanced features and precision engineering, this product meets the highest standards of medical devices compliance and safety.

Similar devices

Also classified as Invasive blood pressure transducer 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 ad99ddd8-9623-498e-ba5f-65b2f3100e83 33 fields · synced Oct 6, 2026