EDGE SYSTEM 11996-000090
GUDID 50883873784933
EDGE System RTS (Radiotransparent) Electrodes with QUIK-COMBO Connector
PHYSIO-CONTROL, INC.
External defibrillation electrode, adult, single-use| Primary Device ID | 50883873784933 |
| NIH Device Record Key | f4982598-b1f4-4f0b-abad-aaedfadd47ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EDGE SYSTEM |
| Version Model Number | 11996 |
| Catalog Number | 11996-000090 |
| 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
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00721902195037 [Previous] |
| GS1 | 00883873784938 [Primary] |
| GS1 | 30883873784939 [Package] Contains: 00883873784938 Package: pack [10 Units] In Commercial Distribution |
| GS1 | 50883873784933 [Package] Contains: 30883873784939 Package: case [50 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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-07-06 |
| Device Publish Date | 2020-11-03 |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.