Mainstay Tunneler

FDA UDI

Class III (US FDA UDI)

by Mainstay Medical Limited

Identity

Trade Name: Mainstay Tunneler FDA UDI
Generic Name: Subcutaneous tunneller, single-use FDA UDI
Device Name: Tunneler, US configuration FDA UDI
Model / Reference: 7MTUN1-002 FDA UDI
Description: Tunneler, US configuration FDA UDI

Identifiers

Catalog Number: TUN1 FDA UDI
Primary DI / UDI-DI: 05391527772415 FDA UDI
PMA Number: P190021 FDA UDI
FDA Product Code: QLK FDA UDI
GMDN Term: Subcutaneous tunneller, single-use FDA UDI

Classification

Device Class: Class III 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Subcutaneous tunneller, single-use

Mainstay Tunneler by Mainstay Medical Limited — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Subcutaneous tunneller, single-use.

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PMT® CORPORATION — Pmt Corp. · Class I
Halyard — Avanos Medical, Inc. · Class II
AVANOS — Avanos Medical, Inc. · Class II
Halyard — Avanos Medical, Inc. · Class II
Argyle — Mozarc Medical US LLC · Class II

Cleared under the same submission

P190021 also covers:

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 III	Pending data

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Manufacturer

Manufacturer: Mainstay Medical Limited

Sources (1)

FDA UDI 741be66b-4d63-4ecd-9a2a-0edf0d2ec6ef 36 fields · synced May 31, 2026