ONESTEP
GUDID 00847946021221
ONESTEP CPR COMPLETE ELECTRODE, FC, SINGLE
BIO-DETEK INCORPORATED
Rechargeable professional automated external defibrillator| Primary Device ID | 00847946021221 |
| NIH Device Record Key | d1b58ac7-65c0-4663-ba0f-69721bcf25c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONESTEP |
| Version Model Number | 8900-000420-01 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847946021221 [Primary] |
| GS1 | 10847946021228 [Package] Package: [8 Units] In Commercial Distribution |
FDA Product Code
| LIX | Aid, cardiopulmonary resuscitation |
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 | 2016-08-03 |
On-Brand Devices [ONESTEP]
| 00847946021238 | ONESTEP PACING ELECTRODE, FC, SINGLE |
| 00847946021221 | ONESTEP CPR COMPLETE ELECTRODE, FC, SINGLE |
| 00847946021160 | ONESTEP CPR COMPLETE ADULT/CHILD ELECTRODE, SINGLE |
| 00847946016272 | ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES |
| 00847946016265 | ELECTRODES, ONESTEP CPR, SINGLE, R SERIES |
| 00847946016258 | ELECTRODES, ONESTEP PACING, SINGLE, R SERIES |
| 00847946016241 | ELECTRODES, ONESTEP BASIC, SINGLE, R SERIES |
Trademark Results [ONESTEP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ONESTEP 98490946 not registered Live/Pending |
ZUBAIR YOUSAF 2024-04-10 |
 ONESTEP 87814465 not registered Dead/Abandoned |
Edward J. Noble 2018-02-28 |
 ONESTEP 87730984 not registered Live/Pending |
Interplastic Corporation 2017-12-21 |
 ONESTEP 87610297 5452194 Live/Registered |
Lumry, Christopher 2017-09-15 |
 ONESTEP 87542423 not registered Live/Pending |
PLR IP Holdings, LLC 2017-07-25 |
 ONESTEP 87542387 not registered Live/Pending |
PLR IP Holdings, LLC 2017-07-25 |
 ONESTEP 87041734 5320204 Live/Registered |
Standard Textile Co., Inc. 2016-05-18 |
 ONESTEP 86014406 not registered Dead/Abandoned |
Noble Ideas II, LLC 2013-07-18 |
 ONESTEP 85849717 4531803 Live/Registered |
MOLECULAR DEVICES, LLC 2013-02-14 |
 ONESTEP 85149370 4270488 Dead/Cancelled |
Beam, Longest & Neff, L.L.C. 2010-10-11 |
 ONESTEP 78765490 3198418 Live/Registered |
LSC COMMUNICATIONS US, LLC 2005-12-02 |
 ONESTEP 78620120 not registered Dead/Abandoned |
GMAC MORTGAGE LLC 2005-04-29 |
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