NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE

K955657 · North State Plastics, Inc. · BYP · Mar 12, 1996 · Anesthesiology

Device Facts

• Record ID: K955657
• Device Name: NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
• Applicant: North State Plastics, Inc.
• Product Code: BYP · Anesthesiology
• Decision Date: Mar 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5620
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The North State Plastics Respiratory Mouthpiece is intended for use in providing a direct source of continuous aerosol medication.

Device Story

Respiratory mouthpiece; injection-molded high-density polyethylene; 22mm OD fitting; connects to standard aerosol delivery devices; provides direct source of continuous aerosol medication; used in clinical or home settings; operated by patients or clinicians; facilitates medication inhalation; simplistic design.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: High Density Polyethylene (chemically inert); Form factor: Injection molded; Connection: Standard 22mm OD fitting; Energy source: None (passive); Connectivity: None; Sterilization: Not specified.

Indications for Use

Indicated for patients requiring continuous aerosol medication delivery via respiratory devices.

Regulatory Classification

Identification

A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.

Reference Devices

• Hudson
• Baxter
• Marquest
• Pari
• Precision
• Salter

Submission Summary (Full Text)

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K955657

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS :

The North State Plastics Respiratory Mouthpiece has been found to be substantially equivalent to currently marketed devices (e.g. Hudson, Baxter, Marquest, Pari, Precision, and Salter).

Like the predicate devices, the North State Plastics Respiratory Mouthpiece is intended for use in providing a direct source of continuous aerosol medication. The North State Plastics device performs the same function as alternative referenced devices.

The device is injection molded from rigid, clean, chemically inert High Density Polyethylene. The Mouthpiece is equipped with a standard 22mm OD fitting for connection to most aerosol devices. Competitively marketed devices utilize essentially the same component materials.

The North State Plastics Respiratory Mouthpiece is simplistic in design and easily used in multiple respiratory applications.

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