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Quantien™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
QUANTIEN™ FDA UDI
Generic Name
Cardiac catheterization laboratory computer FDA UDI
Device Name
Diagnostic Computer FDA UDI
Model / Reference
Measurement System FDA UDI
Description
Diagnostic Computer FDA UDI

Identifiers

Catalog Number
C12787 FDA UDI
Primary DI / UDI-DI
05415067000996 FDA UDI
FDA Product Code
DQK FDA UDI
DSK FDA UDI
GMDN Term
Cardiac catheterization laboratory computer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
870.1110 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

Yes

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

Category: Cardiac catheterization laboratory computer

Quantien™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac catheterization laboratory computer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
St. Jude Medical, Inc.

Sources (1)

  • FDA UDI 4e6f54a4-0887-412e-b839-669bff31b45f 36 fields · synced Jun 8, 2026