NORTH STATE PLASTICS AEROSOL TEE

K955656 · North State Plastics, Inc. · BYX · Mar 6, 1996 · Anesthesiology

Device Facts

• Record ID: K955656
• Device Name: NORTH STATE PLASTICS AEROSOL TEE
• Applicant: North State Plastics, Inc.
• Product Code: BYX · Anesthesiology
• Decision Date: Mar 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5860
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The North State Plastics Aerosol Tee is intended for use in providing a conduit for aerosol medications and respiratory gases.

Device Story

Device functions as conduit for aerosol medications and respiratory gases; connects to aerosol delivery systems via standard 18mm and 22mm OD fittings. Used in clinical or home respiratory care settings; operated by clinicians or patients. Injection-molded design facilitates integration into various respiratory circuits. Simplistic design ensures compatibility with existing aerosol therapy equipment.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Injection-molded clear, rigid, chemically inert K-Resin KRO3-NW. Standard 18mm and 22mm OD fittings. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring aerosol medication delivery or respiratory gas administration via standard aerosol configurations.

Regulatory Classification

Identification

Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.

Predicate Devices

• Hudson (not specified)
• Baxter (not specified)
• B & B (not specified)
• Marquest (not specified)

Submission Summary (Full Text)

{0}

K (illegible handwritten note)
MAR - 6 1996

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS :

The North State Plastics Aerosol Tee has been found to be substantially equivalent to currently marketed devices (e.g. Hudson, Baxter, B & B, and Marquest).

Like the predicate devices, the North State Plastics Aerosol Tee is intended for use in providing a conduit for aerosol medications and respiratory gases. The North State Plastics device performs the same function as alternative referenced devices.

The device is injection molded from clear, rigid, clean, chemically inert K-Resin KRO3-NW. The Aerosol Tee is equipped with standard 18 and 22 mm OD fittings for connection to most aerosol devices. Competitively marketed devices utilize essentially the same component materials.

The North State Plastics Aerosol Tee is simplistic in design and easily used in multiple respiratory aerosol configurations.

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