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SynCardia Companion 2 Driver

FDA UDI

Class III (US FDA UDI)

by SynCardia Systems, LLC

Identity

Trade Name
SynCardia Companion 2 Driver FDA UDI
Generic Name
Ventricular prosthesis system, pneumatically-powered FDA UDI
Model / Reference
397002-001 FDA UDI

Identifiers

Primary DI / UDI-DI
00858000003107 FDA UDI
PMA Number
P030011 FDA UDI
FDA Product Code
LOZ FDA UDI
GMDN Term
Ventricular prosthesis system, pneumatically-powered FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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
MRI Safety
MR Unsafe FDA UDI

Category: Ventricular prosthesis system, pneumatically-powered

SynCardia Companion 2 Driver by SynCardia Systems, LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ventricular prosthesis system, pneumatically-powered.

Cleared under the same submission

P030011 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SynCardia Systems, LLC

Sources (1)

  • FDA UDI 6c33b8bd-d326-41d5-826e-0000a3ad9faf 35 fields · synced Jun 9, 2026