ReviveR

GUDID 00815098020027

DEFIBTECH, L.L.C.

Non-rechargeable public semi-automated external defibrillator

• Primary Device ID: 00815098020027
• NIH Device Record Key: 5dfe96e7-dd11-4be7-a07d-83e959e8f8d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReviveR
• Version Model Number: DDU-100B
• Company DUNS: 128340200
• Company Name: DEFIBTECH, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815098020027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013896

FDA Product Code

• MKJ: Automated External Defibrillators (Non-Wearable)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

Devices Manufactured by DEFIBTECH, L.L.C.

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• 10815098020482 - DDU-1XX Series Adult Pads Adapter, Zoll Configuration: 2024-06-06
• 10815098020499 - DDU-1XXX/2XXX Adult Pads Adapter, Physio-Control Configuration: 2024-06-06
• 10815098020505 - DDU-1XXX/2XXX Adult Pads Adapter, Zoll Configuration: 2024-06-06
• 10815098020512 - DDU-2XXX Series ECGMA Cable, AAMI Configuration: 2024-06-06
• 10815098020529 - DDU-2XXX Series ECGMA Cable, IEC Configuration: 2024-06-06
• 10815098020437 - DDU-1XX Series Pediatric Pads Configuration: 2023-07-06
• 10815098020451 - DDU-1XXX/2XXX Series Pediatric Pads Configuration: 2023-07-06