Cardio Clear H404
GUDID 10814907020217
RadioTransparent Defibrillation Electrodes, Philips Plug Connector
CARDIO-MEDICAL PRODUCTS, INC.
External defibrillator electrode, adult, single-use| Primary Device ID | 10814907020217 |
| NIH Device Record Key | a7ef4d02-3502-4f56-a039-d393ae381534 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cardio Clear |
| Version Model Number | H404 |
| Catalog Number | H404 |
| Company DUNS | 029286150 |
| Company Name | CARDIO-MEDICAL PRODUCTS, 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com | |
| Phone | 9735869500 |
| info@cardiomedicalproducts.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814907020210 [Primary] |
| GS1 | 10814907020217 [Package] Contains: 00814907020210 Package: Box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103159
FDA Product Code
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) |
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 | 2015-07-28 |
On-Brand Devices [Cardio Clear]
| 10814907020323 | Radiotranslucent Pediatric Defibrillation Electrodes, Zoll Connector |
| 10814907020316 | RadioTransparent Defibrillation Electrodes, Zoll Connector, Leads Out |
| 10814907020309 | Radiotranslucent Defibrillation Electrodes, Zoll Connector |
| 10814907020293 | RadioTransparent Defibrillation Electrodes, Zoll Connector, Leads Out, Short Cord |
| 10814907020286 | RadioTransparent Defibrillation Electrodes, Zoll Connector, Leads Out |
| 10814907020279 | RadioTransparent Defibrillation Electrodes, Zoll Connector |
| 10814907020262 | RadioTransparent Defibrillation Electrodes, Zoll Connector |
| 10814907020255 | Radiotranslucent Pediatric Defibrillation Electrodes, Philips Plug Connector |
| 10814907020248 | RadioTransparent Defibrillation Electrodes, Philips Plug Connector, Leads Out |
| 10814907020231 | Radiotranslucent Defibrillation Electrodes, Philips Plug Connector, Leads Out |
| 10814907020224 | Radiotranslucent Defibrillation Electrodes, Philips Plug Connector |
| 10814907020217 | RadioTransparent Defibrillation Electrodes, Philips Plug Connector |
| 10814907020200 | RadioTransparent Defibrillation Electrodes, Philips Plug Connector |
| 10814907020194 | Radiotranslucent Pediatric Defibrillation Electrodes, Physio Connector |
| 10814907020187 | RadioTransparent Defibrillation Electrodes, Physio-Control Connector, Leads Out |
| 10814907020170 | Radiotranslucent Defibrillation Electrodes, Physio-Control Connector, Leads Out |
| 10814907020163 | Radiotranslucent Defibrillation Electrodes, Physio-Control Connector |
| 10814907020156 | RadioTransparent Defibrillation Electrodes, Physio-Control Connector |
| 10814907020149 | RadioTransparent Defibrillation Electrodes, Physio-Control Connector, Short Cord |
| 10814907020132 | RadioTransparent Defibrillation Electrodes, Physio-Control Connector |
| 10814907020125 | Radiotranslucent Pediatric Defibrillation Electrodes, Philips Barrel Connector |
| 10814907020118 | RadioTransparent Defibrillation Electrodes, Philips Barrel Connector, Leads Out |
| 10814907020101 | RadioTranslucent Defibrillation Electrodes, Zoll Connector, Leads Out |
| 10814907020095 | Radiotranslucent Defibrillation Electrodes, Philips Barrel Connector, Leads Out |
| 20814907020085 | Radiotranslucent Defibrillation Electrodes, Philips Barrel Connector |
| 10814907020071 | RadioTransparent Defibrillation Electrodes, Anderson Connector |
| 10814907020064 | RadioTransparent Defibrillation Electrodes, Philips Plug Connector |
| 10814907020057 | RadioTransparent Defibrillation Electrodes, Philips Barrel Connector |
| 10814907020040 | Radiotranslucent Pediatric Defibrillation Electrodes, Anderson Connector |
| 10814907020033 | RadioTransparent Defibrillation Electrodes, Anderson Connector, Leads Out |
| 10814907020026 | RadioTranslucent Defibrillation Electrodes, Anderson Connector, Leads Out |
| 00814907020012 | RadioTranslucent Defibrillation Electrodes, Anderson Connector |
| 00814907020005 | RadioTransparent Defibrillation Electrodes, Anderson Connector |
Trademark Results [Cardio Clear]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDIO CLEAR 86633160 not registered Dead/Abandoned |
SGS RESEARCH 2015-05-18 |
 CARDIO CLEAR 86111368 4983642 Live/Registered |
Cardio Medical Products, Inc. 2013-11-06 |
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