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Tunneler

FDA UDI

Class I (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name
Tunneler FDA UDI
Generic Name
Vascular port/catheter FDA UDI
Device Name
Tunneler For Use with Bard Access Systems Open-Ended Catheters and BardPort Subcutaneous Ports with Open-Ended Catheters FDA UDI
Model / Reference
0601930 FDA UDI
Description
Tunneler For Use with Bard Access Systems Open-Ended Catheters and BardPort Subcutaneous Ports with Open-Ended Catheters FDA UDI

Identifiers

Catalog Number
0601930 FDA UDI
Primary DI / UDI-DI
00801741085246 FDA UDI
FDA Product Code
MDM FDA UDI
GMDN Term
Vascular port/catheter FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vascular port/catheter

Tunneler by Bard Access Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular port/catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 67ffc825-63d8-4a8e-b080-98fc3db98a13 35 fields · synced Jun 9, 2026