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Remote Assistant III

FDA UDI

Class II (US FDA UDI)

by BIOTRONIK SE & Co. KG

Identity

Trade Name
Remote Assistant III FDA UDI
Generic Name
Implantable cardiac monitor programmer/transmitter/alarm FDA UDI
Model / Reference
435292 FDA UDI

Identifiers

Catalog Number
435292 FDA UDI
Primary DI / UDI-DI
04035479158330 FDA UDI
510(k) Number
K190548 FDA UDI
FDA Product Code
MXD FDA UDI
GMDN Term
Implantable cardiac monitor programmer/transmitter/alarm FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 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

No

FDA UDI

Category: Implantable cardiac monitor programmer/transmitter/alarm

Remote Assistant III by BIOTRONIK SE & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable cardiac monitor programmer/transmitter/alarm.

Cleared under the same submission

K190548 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 1e74199c-1dde-483c-ab2d-80cd66094cea 36 fields · synced May 31, 2026