Medipart Dispos. Xenon 133 Admin. Set Mp-0133M

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K853576 ↗

FDA Product Code

IYT

Device Class

Class II

Regulation

21 CFR Part 892.1390

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Medipart Corrugated Polyethylene & E.V.A. Tubing

  Class I

  FDA 510(k) K853569 Active Cleared 7 Nov 1985

• Medipart Soda Lime Mp-3522

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  FDA 510(k) K853571 Active Cleared 29 Oct 1985

• Medipart Xenon Breathing Kit Mp-Oixm-I

  Class II

  FDA 510(k) K850366 Active Cleared 30 Apr 1985

• Mp-Xmv Disposable Face Mask

  Class I

  FDA 510(k) K862783 Active Cleared 1 Aug 1986

• Medipart Radioaerosol Delivery Sys for Ultravent S

  Class I

  FDA 510(k) K854551 Active Cleared 19 Dec 1985

• Medipart Xenon Breathing Kit Mp-02XM-I

  Class II

  FDA 510(k) K850367 Active Cleared 30 Apr 1985

See all devices from Medipart Jerry Alexander →

• What is the Medipart Disposable Xenon-133 Administration Set MP-0133M used for?

  The MP-0133M is a rebreathing system designed specifically for the administration of Xenon-133 gas, a radiopharmaceutical used in medical imaging. It enables clinicians to evaluate lung ventilation and perfusion through non-invasive inhalation imaging, primarily in radiology settings. This diagnostic tool helps assess lung function by allowing patients to inhale the gas, which is then detected to create detailed images of lung activity.

• Is the MP-0133M sterile and single-use, or can it be reused?

  The MP-0133M is supplied as a sterile, single-use disposable kit. This design ensures patient safety by preventing cross-contamination and maintaining sterility between uses. After a single procedure, the device must be discarded in accordance with radiopharmaceutical safety protocols and sterile disposable medical device guidelines.

• What regulatory approval does the MP-0133M hold, and where is it classified?

  The MP-0133M holds FDA 510(k) clearance under the reference number K853576, classified as substantially equivalent to a predicate device. It falls under the product code IYT and adheres to regulation 892.1390, which governs rebreathing systems for radionuclide imaging. This classification ensures it meets stringent safety and performance standards for diagnostic radiology applications.

• Can the MP-0133M be used in MRI environments, or is it restricted to radiology?

  The MP-0133M is explicitly designed for use in radiology settings and is not intended for MRI environments. Its primary purpose is the administration of Xenon-133 for lung ventilation and perfusion imaging, which requires compliance with radiopharmaceutical safety protocols. Using it in MRI settings could compromise imaging accuracy or patient safety.

• How should the MP-0133M be stored and handled to maintain integrity?

  The MP-0133M must be stored and handled as a sterile disposable medical device, following standard protocols for radiopharmaceutical administration sets. It should be kept in its original packaging until use to preserve sterility. After opening, it must be used immediately and discarded after a single procedure. Proper containment and disposal are critical to prevent contamination and ensure compliance with regulatory requirements.