| Primary Device ID | 00847946016494 |
| NIH Device Record Key | 22f2aa30-505c-4ed3-abe7-7da4fa06e9b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STAT-PADZ |
| Version Model Number | 8900-5001 |
| 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 | 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 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847946016494 [Primary] |
| GS1 | 10847946016491 [Package] Package: CASE [12 Units] In Commercial Distribution |
| DRX | Electrode, electrocardiograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2014-09-24 |
| 00847946021184 | STAT-PADZ ADULT/CHILD ELECTRODE, SINGLE |
| 00847946016494 | STAT PADZ, ZOLL DEFIB ADULT, 1-SET, INT |
| 00847946016456 | STAT*PADZ HVP MULTI-FUNCTION ELECTRODES - 1 PAIR |
| 00847946016340 | STAT-PADZ PROPAQ MD ADULT ELECTRODES, SINGLE |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STAT-PADZ 74444294 1944530 Live/Registered |
Zoll Medical Corporation 1993-10-05 |