Tunneler

FDA UDI

Class I (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name: Tunneler FDA UDI
Generic Name: Subcutaneous tunneller, single-use FDA UDI
Device Name: 8 in. Malleable Tunneler FDA UDI
Model / Reference: 5688000 FDA UDI
Description: 8 in. Malleable Tunneler FDA UDI

Identifiers

Catalog Number: 5688000 FDA UDI
Primary DI / UDI-DI: 00801741085475 FDA UDI
FDA Product Code: MDM FDA UDI
GMDN Term: Subcutaneous tunneller, single-use 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 20 Centimeter FDA UDI
Outer Diameter — 3 Millimeter FDA UDI

Category: Subcutaneous tunneller, single-use

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

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AVANOS — Avanos Medical, Inc. · Class II
Halyard — Avanos Medical, Inc. · Class II
Mainstay Tunneler — MAINSTAY MEDICAL LIMITED · Class III

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Bard Access Systems, Inc.

Sources (1)

FDA UDI 56be0dec-732d-40e3-bc68-f0d43b0c4fab 36 fields · synced Jun 9, 2026