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EnSite™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
EnSite™ FDA UDI
Generic Name
Cardiac mapping system application software FDA UDI
Device Name
X EP System Live Export Software License FDA UDI
Model / Reference
ENSITE-LE-01 FDA UDI
Description
X EP System Live Export Software License FDA UDI

Identifiers

Catalog Number
ENSITE-LE-01 FDA UDI
Primary DI / UDI-DI
05415067037732 FDA UDI
510(k) Number
K212061 FDA UDI
K221213 FDA UDI
K223094 FDA UDI
K231415 FDA UDI
K242016 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Cardiac mapping system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac mapping system application software

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

Similar devices

Also classified as Cardiac mapping system application software.

Cleared under the same submission

K212061 also covers:

K221213 also covers:

K223094 also covers:

K231415 also covers:

K242016 also covers:

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 8c53f2a3-d461-41f6-adba-1c256232718b 37 fields · synced May 30, 2026