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Model 3145

FDA UDI

Class II (US FDA UDI)

by BIOTRONIK SE & Co. KG

Identity

Trade Name
Model 3145 FDA UDI
Generic Name
Implantable pacemaker analyser, intraoperative FDA UDI
Model / Reference
Refurbishment I FDA UDI

Identifiers

Catalog Number
371106 FDA UDI
Primary DI / UDI-DI
04035479143183 FDA UDI
PMA Number
P950037 FDA UDI
FDA Product Code
OVJ FDA UDI
GMDN Term
Implantable pacemaker analyser, intraoperative FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3600 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Model 3145 by BIOTRONIK SE & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P950037 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BIOTRONIK SE & Co. KG

Sources (1)

  • FDA UDI 268f8088-cd8d-476b-810e-b7d9e6a3ffb5 37 fields · synced May 30, 2026