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PACEART OPTIMA™ System

FDA UDI

Class I (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
PACEART OPTIMA™ System FDA UDI
Generic Name
Patient health record information system application software FDA UDI
Device Name
SW POS12D14 PACEART OPTIMA MKT GLBL FDA UDI
Model / Reference
POS12D14 FDA UDI
Description
SW POS12D14 PACEART OPTIMA MKT GLBL FDA UDI

Identifiers

Primary DI / UDI-DI
00643169463523 FDA UDI
510(k) Number
K110693 FDA UDI
FDA Product Code
OUG FDA UDI
DXH FDA UDI
DPS FDA UDI
KRE FDA UDI
GMDN Term
Patient health record information system application software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6310 FDA UDI
870.2920 FDA UDI
870.2340 FDA UDI
870.3640 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

No

FDA UDI

Category: Patient health record information system application software

PACEART OPTIMA™ System by Medtronic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient health record information system application software.

Cleared under the same submission

K110693 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI 6a7c7e11-c3a8-4f96-97ab-4f7176997b37 36 fields · synced Jun 1, 2026