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Rusch

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
RUSCH FDA UDI
Generic Name
Tracheostomy tube, non-reinforced, non-customized, reusable FDA UDI
Device Name
Tracheostomy tube set,short,cuff,phonat. FDA UDI
Model / Reference
IPN041787 FDA UDI
Description
Tracheostomy tube set,short,cuff,phonat. FDA UDI

Identifiers

Catalog Number
120001-000070 FDA UDI
Primary DI / UDI-DI
04026704009862 FDA UDI
510(k) Number
K955564 FDA UDI
FDA Product Code
JOH FDA UDI
GMDN Term
Tracheostomy tube, non-reinforced, non-customized, 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

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 7 Millimeter FDA UDI
Outer Diameter — 10.4 Millimeter FDA UDI

Category: Tracheostomy tube, non-reinforced, non-customized, reusable

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

Similar devices

Also classified as Tracheostomy tube, non-reinforced, non-customized, reusable.

Cleared under the same submission

K955564 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 0023e08e-5608-415d-8fc1-f69d073c0b9d 38 fields · synced May 31, 2026