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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
PDZ301 SPECIAL Z-MED 5X2X85 FDA UDI
Model / Reference
610451 FDA UDI
Description
PDZ301 SPECIAL Z-MED 5X2X85 FDA UDI

Identifiers

Catalog Number
610451 FDA UDI
Primary DI / UDI-DI
04046964328640 FDA UDI
510(k) Number
K122012 FDA UDI
K991977 FDA UDI
FDA Product Code
LIT FDA UDI
OZT FDA UDI
GMDN Term
Cardiac valvuloplasty catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
870.1255 FDA UDI
Commercial Distribution
Not 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

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

Cleared under the same submission

K122012 also covers:

K991977 also covers:

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 ada9ad1d-32e9-4881-91ec-ed3241552264 38 fields · synced May 30, 2026