RESPIFLO

K962872 · Tyco Healthcare Deutschaland GmbH · CAF · Feb 25, 1997 · Anesthesiology

Device Facts

• Record ID: K962872
• Device Name: RESPIFLO
• Applicant: Tyco Healthcare Deutschaland GmbH
• Product Code: CAF · Anesthesiology
• Decision Date: Feb 25, 1997
• Decision: SESD
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For Inhalation and Humidification by way of Sterile Water in a closed system during Inhalation Therapy.

Device Story

RESPIFLO is sterile, endotoxin-free water for inhalation therapy; packaged in disposable, closed-system containers. Used by clinicians in hospital or clinical settings to provide humidification during respiratory therapy. Device functions as a sterile fluid source for nebulizers or humidifiers; ensures patient safety by preventing contamination through closed-system design and single-use disposal. Benefits include reliable, sterile moisture delivery for respiratory support.

Clinical Evidence

Bench testing only. Includes USP compliance for sterility and endotoxin levels, plus 3-year and 5-year stability testing.

Technological Characteristics

Sterile, endotoxin-free water (USP compliant). Closed-system, disposable, single-use container. No electronic or software components.

Indications for Use

Indicated for patients requiring inhalation and humidification therapy via sterile water in a closed system.

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Predicate Devices

• Hudson RCI AQUAPAK

Submission Summary (Full Text)

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K962872

FEB 25 1997

510(K) SUMMARY

RESPIFLO

Applicant:
Kendall GmbH
Raffinieristrasse 18
93333
Neustadt an der Donau
Germany

Contact: Mr. Konrad Schmitt
Telephone: [phone]
FAX: [phone]

Submitted by:
Curtin & Associates International, Inc.
1200 East Street
Dedham, MA 02026

Contact: Mr. William D. Curtin
Telephone: [phone]
FAX: [phone]

Date this Summary was prepared: July 16, 1996

Trade Name: RESPIFLO
Common Name: Sterile Water for Inhalation Therapy

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Legally Marketed Devices in Which Substantial Equivalence is claimed:

## Hudson RCI AQUAPAK

Description of the Device: This product is Sterile Water for Inhalation Therapy. It is packaged in a closed system and it is disposable after one use. The water is sterile and endotoxin free according to the USP. The product is used for Inhalation and Humidification during Inhalation Therapy.

Intended Use of the Device: For Inhalation and Humidification by way of Sterile Water in a closed system during Inhalation Therapy.

Summary of Technological Characteristics: This product is the exact same in nature and design as a currently marketed in the United States as the product used for Inhalation and Humidification during Inhalation Therapy.

Summary of Test Data:

- Sterile Water according to the USP
- Endotoxin free
- 3 year and 5 year Stability Testing
- Closed system and disposable, single use

See Test Data Results in Section 11, “Confidential Testing, Methods and Results.”