Adapter
GUDID 00847946021313
2-CHANNEL Y-ADAPTOR
Zoll Medical Corporation
Rechargeable professional automated external defibrillator| Primary Device ID | 00847946021313 |
| NIH Device Record Key | f4103ac2-7186-40d8-bb01-a0d92095777f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adapter |
| Version Model Number | 9355-0675 |
| Company DUNS | 055363428 |
| Company Name | Zoll Medical Corporation |
| 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 | false |
| 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 |
| Storage Environment Atmospheric Pressure | Between 0 KiloPascal and 0 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847946021313 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142915
FDA Product Code
| DRT | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-16 |
Devices Manufactured by Zoll Medical Corporation
| 00847946049928 - SurePower 4 | 2025-06-26 CHARGER ADAPTER, SUREPOWER 4 |
| 00812394022823 - ZENIX | 2025-06-25 CABLE, MFC, THOR, EC53 |
| 00812394026296 - X SERIES | 2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2/SPCO, BVM, CPR EXPANSION PACK, US, REFURB (T |
| 00812394026302 - X SERIES | 2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2/SPCO, BVM, CPR EXPANSION PACK, US, REFURB (T |
| 00812394026319 - X SERIES | 2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2/SPCO, BVM/TEMP, CPR EXPANSION PACK, US, REFU |
| 00812394026326 - X SERIES | 2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2/SPCO, BVM/TEMP, CPR EXPANSION PACK, US, REFU |
| 00812394026333 - X SERIES | 2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2/SPCO, BVM/TEMP, CPR EXPANSION PACK, US, REFU |
| 00812394026364 - X SERIES | 2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, BVM, NIBP, CPR EXPANSION PACK, CANADIAN, REFURB, (TIER 2) |
Trademark Results [Adapter]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADAPTER 86378265 not registered Dead/Abandoned |
Evident Systems Pty Ltd 2014-08-27 |
 ADAPTER 73183242 1133009 Dead/Cancelled |
WARNER-LAMBERT COMPANY 1978-08-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.