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Pts®

FDA UDI

Class II (US FDA UDI)

by B Braun Interventional Systems, Inc

Identity

Trade Name
PTS® FDA UDI
Generic Name
Cardiac sizing catheter FDA UDI
Device Name
PTS405 PTS BALLOON 40MM X 5CM X 80CM FDA UDI
Model / Reference
613707 FDA UDI
Description
PTS405 PTS BALLOON 40MM X 5CM X 80CM FDA UDI

Identifiers

Catalog Number
613707 FDA UDI
Primary DI / UDI-DI
04046964311055 FDA UDI
510(k) Number
K003320 FDA UDI
FDA Product Code
MJN FDA UDI
GMDN Term
Cardiac sizing catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 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 sizing catheter

Pts® by B Braun Interventional Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac sizing catheter.

Cleared under the same submission

K003320 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 2715ac57-9574-4a16-b70c-0a6c974eee33 37 fields · synced May 30, 2026