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Merit H2O™

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Merit H2O™ FDA UDI
Generic Name
Peripheral vascular guidewire, manual FDA UDI
Model / Reference
00884450057094 FDA UDI

Identifiers

Catalog Number
H2OSTDA1880/A FDA UDI
Primary DI / UDI-DI
00884450057094 FDA UDI
FDA Product Code
DQX FDA UDI
GMDN Term
Peripheral vascular guidewire, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Peripheral vascular guidewire, manual

Merit H2O Wire, Guide, Catheter is a single-use peripheral vascular guidewire designed for percutaneous interventions such as angiography, catheterization, and thrombectomy. Made from durable materials like stainless steel or Nitinol, this device provides precise control and stability during procedures.

Similar devices

Also classified as Peripheral vascular guidewire, manual.

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 7d4dca61-401c-4d84-9402-8c7921b5aba6 34 fields · synced Jul 22, 2026