MOORE MEDICAL ADULT MFE

GUDID 00847946018443

ELECTRODE ASSEMBLY MOORE MEDICAL PRECONNECT MFE - SINGLE

BIO-DETEK INCORPORATED

Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946018443
• NIH Device Record Key: 6ec37cad-47a5-4966-b8d2-bbae6afb65c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOORE MEDICAL ADULT MFE
• Version Model Number: AD-2054-0001
• 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	00847946018443 [Primary]
GS1	10847946018440 [Package]; Package: CASE [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

Devices Manufactured by BIO-DETEK INCORPORATED

• 00847946022044 - ECG: 2021-03-18 3 ECG 2" ROUND ELECTRODES, 3 ELECTRODES / POUCH
• 00847946022068 - ECG: 2021-03-18 30 ECG 1.5" ROUND ELECTRODES, 6 STRIPS OF 5 / POUCH
• 00847946022082 - ECG: 2021-03-18 30 ECG 2" ROUND ELECTRODES, 10 STRIPS OF 3 / POUCH
• 00847946022099 - ECG: 2021-03-18 30 ECG 1.5" ROUND RADIOTRANSLUCENT ELECTRODES, 6 STRIPS OF 5 / POUCH
• 00847946022105 - ECG: 2021-03-18 30 ECG SQUARE ELECTRODES, 6 STRIPS OF 5 / POUCH
• 00847946022136 - ECG: 2021-03-18 4 PEDIATRIC ECG 1.5" ROUND ELECTRODES, 4 ELECTRODES / POUCH
• 00847946022167 - ECG: 2021-03-18 3 PEDIATRIC ECG 1.5" ROUND ELECTRODES, 3 ELECTRODES / POUCH
• 00847946023034 - ECG: 2021-03-18 4 ECG RECTANGULAR RADIOTRANSLUCENT ELECTRODES, 4 ELECTRODES / POUCH