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Provox LaryTube Sizer Kit

FDA UDI

Class I (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name
Provox LaryTube Sizer Kit FDA UDI
Generic Name
Tracheostomy tube, non-reinforced, non-customized, reusable FDA UDI
Device Name
The Provox LaryTube Sizer Kit is intended for use by the prescribing specialist to determine the size(s) of LaryTube that should be prescribed to the patient. The Sizer Kit should be used only by a prescribing specialist who has read the LaryTube Manual. A copy of that manual comes with the Sizer Kit. It can also be viewed on the Internet at www.atosmedical.com. The Sizer LaryTubes are intended for the sizing procedure only. After the correct size(s) have been determined, new LaryTube(s) shall be given to the patient for use. FDA UDI
Model / Reference
7648 FDA UDI
Description
The Provox LaryTube Sizer Kit is intended for use by the prescribing specialist to determine the size(s) of LaryTube that should be prescribed to the patient. The Sizer Kit should be used only by a prescribing specialist who has read the LaryTube Manual. A copy of that manual comes with the Sizer Kit. It can also be viewed on the Internet at www.atosmedical.com. The Sizer LaryTubes are intended for the sizing procedure only. After the correct size(s) have been determined, new LaryTube(s) shall be given to the patient for use. FDA UDI

Identifiers

Catalog Number
7648 FDA UDI
Primary DI / UDI-DI
07331791005329 FDA UDI
FDA Product Code
KAC FDA UDI
GMDN Term
Tracheostomy tube, non-reinforced, non-customized, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Provox LaryTube Sizer Kit by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atos Medical Inc.

Sources (1)

  • FDA UDI 940a7a80-101a-4f0f-92d7-cccd5c2a19e7 36 fields · synced Jun 8, 2026