RESPIFLO/S

K962874 · Curtin & Associates International , Inc. · CAF · Feb 25, 1997 · Anesthesiology

Device Facts

• Record ID: K962874
• Device Name: RESPIFLO/S
• Applicant: Curtin & Associates International , Inc.
• 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/S is a sterile, endotoxin-free water with saline solution for inhalation and humidification therapy. Packaged in a closed, disposable system for single use. Used in clinical settings to provide moisture during respiratory therapy. Healthcare providers attach the system to inhalation equipment to deliver humidified air/gas to patients. Benefits include reduced risk of contamination due to closed-system design and sterile, endotoxin-free composition.

Clinical Evidence

Bench testing only. Testing confirmed USP compliance for sterile water with saline, endotoxin-free status, and stability over 3 and 5-year periods.

Technological Characteristics

Sterile water with saline solution; closed-system disposable container; single-use; USP compliant; endotoxin-free.

Indications for Use

Indicated for inhalation and humidification therapy in patients requiring respiratory support via 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/S

Submission Summary (Full Text)

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FEB 25 1997
K962874

510(K) SUMMARY

RESPIFLO/S

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/S
Common Name: Sterile Water with Saline for Inhalation Therapy
Classification Name: Sterile Water with Saline for Inhalation Therapy

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Legally Marketed Devices in Which Substantial Equivalence is claimed:
Hudson RCI AQUAPAK/S

Description of the Device: This product is Sterile Water with Saline 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 with Saline 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."