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Z-Med™

FDA UDI

Class II (US FDA UDI)

by B Braun Interventional Systems, Inc

Identity

Trade Name
Z-MED™ FDA UDI
Generic Name
Cardiac valvuloplasty catheter FDA UDI
Device Name
SO047 Z-MED 23X4X120 FDA UDI
Model / Reference
611807 FDA UDI
Description
SO047 Z-MED 23X4X120 FDA UDI

Identifiers

Catalog Number
611807 FDA UDI
Primary DI / UDI-DI
04046964338380 FDA UDI
FDA Product Code
OZT FDA UDI
LIT FDA UDI
GMDN Term
Cardiac valvuloplasty catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1255 FDA UDI
870.1250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiac valvuloplasty catheter

Z-Med™ by B Braun Interventional Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac valvuloplasty catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
B Braun Interventional Systems, Inc

Sources (1)

  • FDA UDI 12953a2a-db76-443f-bc4a-8cf2bf18c295 36 fields · synced May 31, 2026