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Smart Monitor

FDA UDI

Class II (US FDA UDI)

by Osprey Medical, Inc.

Identity

Trade Name
Smart Monitor FDA UDI
Generic Name
Contrast medium conservation system FDA UDI
Device Name
The device consists of a Smart Monitor to be used with the DyeVert or DyeTect systems during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media. FDA UDI
Model / Reference
SMART FDA UDI
Description
The device consists of a Smart Monitor to be used with the DyeVert or DyeTect systems during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media. FDA UDI

Identifiers

Primary DI / UDI-DI
00815241020829 FDA UDI
FDA Product Code
DXT FDA UDI
GMDN Term
Contrast medium conservation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Contrast medium conservation system

Smart Monitor by Osprey Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Contrast medium conservation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osprey Medical, Inc.

Sources (1)

  • FDA UDI d54c8101-a6f0-4de9-ada9-d547d8cd75b7 34 fields · synced May 31, 2026