HWD Electrode Set

GUDID 00847946021986

PRO*PADZ HWD device (single kit)

BIO-DETEK INCORPORATED

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• Primary Device ID: 00847946021986
• NIH Device Record Key: a04cebd7-9499-40bd-8f19-8bc69cec8b77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HWD Electrode Set
• Version Model Number: 9610-000181-01
• Company DUNS: 144116225
• Company Name: BIO-DETEK INCORPORATED
• Device Count: 1
• DM Exempt: true
• 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: 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 Dimensions

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Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946021986 [Primary]

FDA Product Code

• DTE: PULSE-GENERATOR, PACEMAKER, EXTERNAL

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: 2016-10-20

Devices Manufactured by BIO-DETEK INCORPORATED

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• 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