Anesthesia System A7

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• • Terminated Z-0847-2018 FDA Class II ·initiated 14 Jul 2017

  A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.

• • Terminated Z-2692-2016 FDA Class II ·initiated 4 Aug 2016

  Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.

• • Terminated Z-2689-2016 FDA Class II ·initiated 15 Jun 2016

  Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.

Full name

Anesthesia System

Trade Name

Anesthesia System EUDAMED

A7 Anesthesia System GUDID

Generic Name

Anaesthesia unit, mobile

Model / Reference

A7

Primary DI / UDI-DI

06944904039695

Basic UDI-DI

B-06944904039695

510(k) Number

K142552 ↗

K253330 ↗

FDA Product Code

BSZ

EMDN Code

Z1203010101 Anaesthesia devices

GMDN Term

Anaesthesia unit, mobile

Device Class

Class IIb EUDAMED

Class II GUDID

Regulation Number

868.5160

EU market of registration

Germany

GUDID distribution status

In Commercial Distribution

MRI Safety

MR Unsafe

EUDAMED SRN

CN-MF-000014156

Authorised representative

Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

• Chemistry Analyzer

  Class A

  CE/IVDR

• D-Dimer Assay Kit (Immunoturbidimetry Method)

  Class C

  CE/IVDR

• Patient monitor

  Class IIb

  CE/MDR

• Digital Radiography System

  Class IIb

  CE/MDR

• Anti-Thyrotropin Receptor Antibody (CLIA)

  Class B

  CE/IVDR

• Smoke Evacuator

  Class I

  CE/MDR

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

• Is this anesthesia system designed for single-use or can it be reused after cleaning and sterilization?

  The Anesthesia System A7 is explicitly labeled as non-reusable (REUSABLE: 0) and non-sterile (STERILE: 0). It is intended for use in clinical settings like operating rooms and recovery areas, but the manufacturer’s guidelines must be followed for storage and handling to maintain functionality. Reprocessing is not supported or validated for this device.

• What types of anesthetic gases and volatile agents can this system deliver, and how does it ensure precise control?

  The Anesthesia System A7 is designed to deliver precise control of anesthetic gases, oxygen, and volatile agents, as stated in its description. While the specific agents aren’t listed, its active components (ACTIVE: 1) are engineered to ensure accurate dosing and real-time monitoring of vital parameters, enhancing patient safety during surgical procedures.

• How do I identify the correct model and ensure traceability for this device in my facility?

  The Anesthesia System A7 is the specific model referenced (DEVICE_MODEL: A7). For traceability, it carries a unique Basic UDI identifier (B-06944904039695), which helps track the device through its lifecycle. This identifier is tied to the manufacturer’s UDI data (BASIC_UDI_DATA_ULID: 01KNKHYDPCABHSN09930QHZWEN) for regulatory and inventory purposes.

• Does this system include monitoring capabilities for patient vitals, and if so, what parameters are tracked?

  Yes, the Anesthesia System A7 integrates real-time monitoring of vital parameters (as described in the specifications). While the exact parameters aren’t detailed, the system is designed to support active monitoring during anesthesia administration, ensuring patient safety by continuously assessing critical signs during surgical procedures.

• Who is the authorized distributor or representative for this device in Europe, and how can I verify its legitimacy?

  In Europe, the authorized representative for the Anesthesia System A7 is Shanghai International Holding Corp. GmbH (AR_NAME), with the SRN identifier DE-AR-000000001. This entity is responsible for ensuring compliance with European regulations (MDD authorization) and can provide documentation to verify the device’s legitimacy and regulatory status.