DURA-PADZ
GUDID 00847946016296
ELECTRODE, DURA-PADZ REUSABLE
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 | 00847946016296 |
| NIH Device Record Key | d6ed6bdd-7e1a-4928-835b-c5f20121ba0a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DURA-PADZ |
| Version Model Number | 8900-0300 |
| 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 | true |
| 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
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 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 |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847946016296 [Primary] |
| GS1 | 10847946016293 [Package] Package: CASE [12 Units] In Commercial Distribution |
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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2014-09-24 |
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 |
Trademark Results [DURA-PADZ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURA-PADZ 86482856 4743761 Live/Registered |
ZOLL Medical Corporation 2014-12-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.