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Home Monitoring Service Center

FDA UDI

Class III (US FDA UDI)

by BIOTRONIK SE & Co. KG

Identity

Trade Name
Home Monitoring Service Center FDA UDI
Generic Name
Patient health record information system FDA UDI
Model / Reference
3.43 FDA UDI

Identifiers

Catalog Number
442662 FDA UDI
Primary DI / UDI-DI
04035479161750 FDA UDI
PMA Number
P950037 FDA UDI
FDA Product Code
OSR FDA UDI
GMDN Term
Patient health record information system FDA UDI

Classification

Device Class
Class III 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Home Monitoring Service Center by BIOTRONIK SE & Co. KG — Class III — 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 fa5e0713-4828-485e-bd7a-0b82f4e6fc76 36 fields · synced Jun 1, 2026