Rusch

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: RUSCH FDA UDI
Generic Name: Tracheostomy tube neck holder, reusable FDA UDI
Device Name: Neck band, blue, for adults FDA UDI
Model / Reference: IPN044706 FDA UDI
Description: Neck band, blue, for adults FDA UDI

Identifiers

Catalog Number: 507900-000000 FDA UDI
Primary DI / UDI-DI: 04026704064670 FDA UDI
510(k) Number: K955564 FDA UDI
FDA Product Code: JOH FDA UDI
GMDN Term: Tracheostomy tube neck holder, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5800 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: Tracheostomy tube neck holder, reusable

Rusch by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheostomy tube neck holder, reusable.

TRACOE care — Tracoe medical GmbH · Class I
EZCare Softouch - 5" Camo (N9105CO-B) — Neotech Products LLC · Class I
EZ Trach Tie — Dynarex Corp. · Class I
EZ Trach Tie — Dynarex Corp. · Class I
InHealth Technologies; Blom-Singer — FREUDENBERG MEDICAL, LLC · Class I
Dale 240 Blue — Dale Medical Products, Inc. · Class I
Argyle — Cardinal Health 200, LLC · Class I
EZCare Softouch - 5" Blue (N9105BL-B) — Neotech Products LLC · Class I

Cleared under the same submission

K955564 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 II	Pending data

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Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI 42098fac-613c-4e3e-881a-7ee519c64817 37 fields · synced Jun 6, 2026