EDGE SYSTEM 11996-000093
GUDID 50883873784957
Pediatric EDGE System RTS (Radiotransparent) Electrodes with QUIK-COMBO Connector
PHYSIO-CONTROL, INC.
External defibrillator electrode, paediatric, single-use External defibrillator electrode, paediatric, single-use External defibrillator electrode, paediatric, single-use External defibrillator electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use External defibrillation electrode, paediatric, single-use| Primary Device ID | 50883873784957 |
| NIH Device Record Key | d6316430-ea56-4cc7-a7ce-c4e85cec3629 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EDGE SYSTEM |
| Version Model Number | 11996 |
| Catalog Number | 11996-000093 |
| 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
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -30 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00721902207501 [Previous] |
| GS1 | 00883873784952 [Primary] |
| GS1 | 30883873784953 [Package] Contains: 00883873784952 Package: pack [5 Units] In Commercial Distribution |
| GS1 | 50883873784957 [Package] Contains: 30883873784953 Package: case [25 Units] In Commercial Distribution |
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 | 2020-11-10 |
| Device Publish Date | 2020-11-02 |
On-Brand Devices [EDGE SYSTEM]
| 50883873784957 | Pediatric EDGE System RTS (Radiotransparent) Electrodes with QUIK-COMBO Connector |
| 50883873784964 | EDGE System Electrodes with QUIK-COMBO Connector and REDI-PAK Preconnect System |
| 50883873784940 | EDGE System Electrodes with QUIK-COMBO Connector |
| 50883873784933 | EDGE System RTS (Radiotransparent) Electrodes with QUIK-COMBO Connector |
Trademark Results [EDGE SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EDGE SYSTEM 86564409 not registered Dead/Abandoned |
Magic Leap, Inc. 2015-03-15 |
 EDGE SYSTEM 85765680 4367505 Live/Registered |
EDGE FINANCE, LLC 2012-10-29 |
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