ONESTEP
GUDID 00847946016265
ELECTRODES, ONESTEP CPR, SINGLE, R SERIES
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 | 00847946016265 |
| NIH Device Record Key | c8bb331d-aec3-4c9e-b454-2c1ccfe08123 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONESTEP |
| Version Model Number | 8900-0223-01 |
| 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 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 | 00847946016265 [Primary] |
| GS1 | 10847946016262 [Package] Package: CASE [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 | 2014-09-24 |
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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