DEFIB Pads D326

GUDID 00081350020008

Cardiac Science Adult AED Pad

GRAPHIC CONTROLS ACQUISITION CORP

External defibrillator electrode pad

• Primary Device ID: 00081350020008
• NIH Device Record Key: 2f0bd61a-3c98-46a0-9693-6738765d0b08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEFIB Pads
• Version Model Number: D326
• Catalog Number: D326
• Company DUNS: 002111896
• Company Name: GRAPHIC CONTROLS ACQUISITION CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18024639976
• Email: mfillion@vermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00081350020008 [Primary]
GS1	10813150020005 [Package]; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131494

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: 2015-04-29

On-Brand Devices [DEFIB Pads]

• 00081350020008: Cardiac Science Adult AED Pad
• 00813150020008: Cardiac Science Adult AED Pad