Quantien™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: QUANTIEN™ FDA UDI
Generic Name: Desk mount FDA UDI
Model / Reference: Measurement System FDA UDI

Identifiers

Catalog Number: C12797 FDA UDI
Primary DI / UDI-DI: 05415067004635 FDA UDI
FDA Product Code: DSK FDA UDI
DQK FDA UDI
GMDN Term: Desk mount FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1110 FDA UDI
870.1425 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Desk mount

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: St. Jude Medical, Inc.

Sources (1)

FDA UDI 5ca239d6-44c0-47c6-a4a0-8583dde27cfa 35 fields · synced Jun 1, 2026