MOORE MEDICAL ADULT MFE

GUDID 00847946018443

ELECTRODE ASSEMBLY MOORE MEDICAL PRECONNECT MFE - SINGLE

BIO-DETEK INCORPORATED

Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator 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