International Medical Devices Database

Manufacturer Address
Defibtech, LLC, 741 Boston Post Rd Ste 201, Guilford CT 06437-2714
Source
USFDA
4 Events

4 devices in the database

Device Recall Sentry semi automatic external defibrillator (AED)

Model / Serial
Data cards are not serialized. Data cards are traced by shipment dates from July 19, 2010 through August 25, 2010.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
USA - Nationwide Distribution and Puerto Rico
Product Description
DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). || The DDC-6-AA data card is an accessory to the AED and does not have its own intended use.

Defibtech Lifeline AED and ReviveR AED

Model / Serial
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and countries including: AUSTRALIA, AUSTRIA , BAHRAIN, BRAZIL, CANADA, CHILE, CHINA , CYPRUS, CZECH REPUBLIC, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JORDAN, KOREA, REPUBLIC OF LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NORWAY, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM AND URUGUAY.
Product Description
Defibtech Lifeline AED and ReviveR AED, || Model: DDU-100 Series AEDs || Software version 2.004 or earlier || The product under correction is the DDU-100 AED. The AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is unconscious, unresponsive and not breathing. The indications for use also state that for patients under 8 years old, child/ infant electrode pads are to be used and that therapy should not be delayed to determine the patients exact age or weight. The AED must also be used by or on the order of a physician. These AEDs are sold under the brand names Lifeline AED and ReviveR AED.

Device Recall ReviveR AEDDefibtech Sentry

Model / Serial
Software versions earlier than version 2.002
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide distribution ---- USA and countries of Canada, Uruguay, Jordon, Turkey United Kingdom, Saudi Arabia, Sweden France, South Africa, Cyprus, Spain, Germany India, Japan, Israel, Australia, Norway, Philppines Singapore, Poland, Germany, Italy, Switzerland Netherlands, Indonesia, United Arab Emirates Malaysia, Austria, Ireland, Kingdom of Bahrain, and Korea.
Product Description
Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand -Model DDU-100B (version 2.002 and earlier)

Device Recall Lifeline AEDDefibtech Sentry

Model / Serial
Model DDU 100A-Software versions earlier than version 2.002
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide distribution ---- USA and countries of Canada, Uruguay, Jordon, Turkey United Kingdom, Saudi Arabia, Sweden France, South Africa, Cyprus, Spain, Germany India, Japan, Israel, Australia, Norway, Philppines Singapore, Poland, Germany, Italy, Switzerland Netherlands, Indonesia, United Arab Emirates Malaysia, Austria, Ireland, Kingdom of Bahrain, and Korea.
Product Description
Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier)

2 manufacturers with a similar name

Learn more about the data here

Defibtech, LLC

Manufacturer Parent Company (2017)
Nihon Kohden Corp.
Source
SATP

Defibtech, LLC

Manufacturer Parent Company (2017)
Nihon Kohden Corp.
Source
ORMPMDBP

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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