QUIK-STEP 11103-000026
GUDID 00883873871577
ELECTRODES, 5-YEAR, LPCR2
PHYSIO-CONTROL, INC.
External defibrillator electrode, adult, single-use| Primary Device ID | 00883873871577 |
| NIH Device Record Key | c6b65bda-d309-4c39-a7d2-7dd4a29d9678 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QUIK-STEP |
| Version Model Number | 11103 |
| Catalog Number | 11103-000026 |
| Company DUNS | 009251992 |
| Company Name | PHYSIO-CONTROL, INC. |
| 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 | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP ELECTRODE AWAY FROM SUNLIGHT. STORAGE AT EXTREME TEMPERATURES OF -30 TO 60 C (-22 TO 140 F) LIMITED TO SEVEN DAYS. EXCEEDING THAT REDUCES THE ELECTRODE SHELF-LIFE. |
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883873871577 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P170018
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-23 |
| Device Publish Date | 2020-10-15 |
Devices Manufactured by PHYSIO-CONTROL, INC.
| 00883873761434 - STANDARD HARD PADDLES | 2024-11-18 PADDLE ASSY - HARD PADDLE, ENGLISH,ROHS,LP15 |
| 00883873761441 - PEDIATRIC PADDLE, EXTERNAL | 2024-11-18 ASSY PEDIATRIC PADDLE,MULTI LANGUAGE, 3RD EDT |
| 00883873777466 - LIFEPAK 15 MONITOR/DEFIBRILLATOR | 2024-11-18 15AABAAABABBBABAAAAAAABFLP15 MONITOR/DEFIB |
| 00883873907252 - NA | 2024-10-28 CABLE-ADAPTER,LP15 INTERNAL PADDLES,ROHS,3RD EDT |
| 00883873761533 - LIFEPAK 35 Monitor/Defibrillator | 2024-09-12 LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR |
| 00883873761540 - LIFEPAK 35 Monitor/Defibrillator | 2024-09-12 LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR |
| 00883873761557 - LIFEPAK 35 Monitor/Defibrillator | 2024-09-12 LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR |
| 00883873761564 - LIFEPAK 35 Monitor/Defibrillator | 2024-09-12 LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR |
Trademark Results [QUIK-STEP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUIK-STEP 86498302 5519860 Live/Registered |
Physio-Control, Inc. 2015-01-08 |
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