DHD ACE With Mask Kit

• • Terminated Z-1516-2021 FDA Class II ·initiated 31 Mar 2021

  The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.

510(k) Number

K961973 ↗

FDA Product Code

CAF

Device Class

Class II

Regulation

21 CFR Part 868.5630

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Dhd Metered Dose Inhaler (Mdi) Spacer (Modification)

  Class II

  FDA 510(k) K953206 Active Cleared 28 Aug 1995

• Dhd Metered Dose Inhaler (Mdi) Spacer

  Class II

  FDA 510(k) K913326 Active Cleared 7 Jan 1992

• Stealth, Metered Dose Inhaler (Mdi) Spacer Without Integral Actuator

  Class II

  FDA 510(k) K973532 Active Cleared 19 Mar 1998

• Duralife

  Class I

  FDA 510(k) K922537 Active Cleared 4 Dec 1992

• Ace Aerosol Enhancer, Hand Held Oral Inhalation Co

  Class II

  FDA 510(k) K926301 Active Cleared 21 Jul 1993

• Duralife(Tm)

  Class I

  FDA 510(k) K913726 Active Cleared 7 Feb 1992

See all devices from Dhd Diemolding Healthcare Div. →

• What is the DHD ACE With Mask Kit used for?

  The DHD ACE With Mask Kit is designed to facilitate inhalation therapy by delivering aerosolized medications directly to the respiratory tract. It pairs a mask interface with an aerosol enhancer to improve drug deposition, making it ideal for administering inhaled treatments like anesthetics or bronchodilators in controlled clinical environments.

• Is the DHD ACE With Mask Kit single-use or reusable?

  The kit is supplied as a single-use device, ensuring hygiene and safety for each patient. However, the mask component within the kit may be reusable or disposable depending on its material specifications—check the manufacturer’s guidelines for proper use and cleaning protocols.

• How should the DHD ACE With Mask Kit be stored?

  Storage instructions are provided by the manufacturer to maintain the device’s functionality. Generally, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the specific storage recommendations included with the kit to preserve its performance for aerosol therapy.

• What regulatory approval does the DHD ACE With Mask Kit have?

  The device holds FDA 510(k) clearance under the classification of anesthesiology (product code CAF), with the clearance number K961973. This means it has been deemed substantially equivalent to a legally marketed device and is regulated under the Anesthesiology Advisory Committee.

• Can the DHD ACE With Mask Kit be used with any inhaler?

  The kit is designed to be compatible with metered-dose inhalers or similar aerosol delivery devices. However, compatibility may depend on the specific inhaler model and the mask component’s design. Always verify the manufacturer’s instructions to ensure proper pairing and functionality for optimal drug delivery.