BIO-DETEK MFE

GUDID 00847946018429

BIO-DETEK INCORPORATED

Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946018429
• NIH Device Record Key: e3766bca-e0d1-4c6e-aa3c-7987941ac935
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO-DETEK MFE
• Version Model Number: AD-2023-0002
• Company DUNS: 144116225
• Company Name: BIO-DETEK INCORPORATED
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946018429 [Primary]
GS1	10847946018426 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• LDD: Dc-Defibrillator, Low-Energy, (Including Paddles)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-23

On-Brand Devices [BIO-DETEK MFE]

• 00847946018429: AD-2023-0002
• 00847946018412: ELECTRODE ASSEMBLY BIO-DETEK PRECONNECT MFE ZOLL CON COMMODITY STYLE - SINGLE
• 00847946018405: ELECTRODE ASSEMBLY BIO-DETEK PRECONNECT MFE PHYSIO CON - SINGLE