RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY

K961840 · Rusch Intl. · BTR · Jun 27, 1996 · Anesthesiology

Device Facts

• Record ID: K961840
• Device Name: RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY
• Applicant: Rusch Intl.
• Product Code: BTR · Anesthesiology
• Decision Date: Jun 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The device is intended for oral or nasal intubation. It is intended for airway management.

Device Story

Clear, implant-tested PVC tracheal tube; includes radiopaque stripe for visualization; graduated centimeter markings for depth determination; available in Magill or Murphy (with side eye) configurations; sizes 2.0-7.0. Used by clinicians for airway management via oral or nasal insertion. Provides patent airway for ventilation; facilitates gas exchange. Device is single-use, sterile.

Clinical Evidence

Bench testing only. Device conforms to ASTM 1242-89 standards and meets biocompatibility requirements per ISO 10993.

Technological Characteristics

Material: Implant-tested PVC; radiopaque stripe. Standards: ASTM 1242-89, ISO 10993 (biocompatibility). Form factor: Tracheal tube with centimeter markings; sizes 2.0-7.0. Configuration: Magill or Murphy (with Murphy eye).

Indications for Use

Indicated for patients requiring oral or nasal intubation for airway management.

Regulatory Classification

Identification

A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

Predicate Devices

• Sheridan Uncuffed Tracheal Tube Magill/Murphy Type

Submission Summary (Full Text)

{0}

K961840
Rusch INTERNATIONAL A Subsidiary of Teleflex Incorporated (USA)

Pines Park
ey, NH 03452
[phone]
FAX [phone]

JUN 27 1996

# Substantial Equivalence 510(k) Summary
Rüsch Oral/Nasal Tracheal Tube, Plain- Magill/Murphy

To: Whom it May Concern

Date: May 10, 1996

## Submitter/Contact- Name and Address:

Miss Karenann J. Brozowski
Group Regulatory Affairs Director
Rüsch International
Tall Pines Park
Jaffrey, NH 03452

Telephone: [phone]
Fax: [phone]

## Device Details:

Trade Name: Rüsch Oral/Nasal Tracheal Tube, Plain- Magill/Murphy

Common Name: Tracheal Tube

Classification Name: Tube, Tracheal(w/wo Connector 73BTR)

Predicate Legally Marketed Device: Sheridan Uncuffed Tracheal Tube Magill/Murphy Type

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## Device Description:

The Rusch Oral/Nasal Tracheal Tube, Plain, Magill/Murphy consists of a clear implant tested PVC tracheal tube with radiopaque stripe. The main tube is graduated with multiple centimeter markings to allow easy determination of intubated length. A black tip area is present on the tube to aid in visualization of the tube. An optional Murphy eye provides an alternative opening. The eye is the difference between the Murphy and the Magill Tube. The device is for Nasal/Oral use.

## Device Intended Use:

The device is intended for oral or nasal intubation. It is intended for airway management.

## Technological Characteristics of the Device:

The device is manufactured according to ASTM 1242-89. It is equivalent in design and intended use with the Sheridan product. Both of the products are PVC with the same general appearance.

The Rusch Tracheal Tube comes in sizes 2.0-7.0 inclusive.

## Bench/Laboratory Testing:

Based on test data, the device conforms to ASTM 1242-89.

The device is biocompatible per the requirements of ISO 10993.