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B.braun

FDA UDI

Class II (US FDA UDI)

by B Braun Interventional Systems, Inc

Identity

Trade Name
B.BRAUN FDA UDI
Generic Name
Peripherally-inserted central venous catheter FDA UDI
Device Name
4F PICC SINGLE 50 NITGOLD 80 CTS450-NG80 FDA UDI
Model / Reference
613400 FDA UDI
Description
4F PICC SINGLE 50 NITGOLD 80 CTS450-NG80 FDA UDI

Identifiers

Catalog Number
613400 FDA UDI
Primary DI / UDI-DI
04046964310546 FDA UDI
510(k) Number
K083873 FDA UDI
FDA Product Code
LJS FDA UDI
GMDN Term
Peripherally-inserted central venous catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5970 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 4.00 French FDA UDI

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

Cleared under the same submission

K083873 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 5840ba61-46ff-4035-a5de-f7e98343bfd9 39 fields · synced May 30, 2026