| Primary Device ID | 00681490580656 |
| NIH Device Record Key | 1dd95b69-a216-41d9-a139-2faf552f5000 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EDGE Electrodes with REDI-PAK™ Preconnect System |
| Version Model Number | 11996 |
| Catalog Number | 11996-000017 |
| Company DUNS | 009251992 |
| Company Name | PHYSIO-CONTROL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00681490580656 [Primary] |
| GS1 | 20681490580650 [Package] Package: Shelf Pak [10 Units] In Commercial Distribution |
| GS1 | 40681490580654 [Package] Contains: 20681490580650 Package: Case [50 Units] In Commercial Distribution |
| MKJ | Automated external defibrillators (non-wearable) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2014-11-10 |
| 50883873784933 - EDGE SYSTEM | 2023-07-06 EDGE System RTS (Radiotransparent) Electrodes with QUIK-COMBO Connector |
| 50883873784940 - EDGE SYSTEM | 2023-07-06 EDGE System Electrodes with QUIK-COMBO Connector |
| 50883873784964 - EDGE SYSTEM | 2023-07-06 EDGE System Electrodes with QUIK-COMBO Connector and REDI-PAK Preconnect System |
| 00883873772676 - Emergency Response Kit | 2023-03-20 Emergency Response Kit |
| 00883873824597 - Replacement Kit for CHARGE-PAK battery charger | 2023-02-28 SHIPPING ASSY-C-P, Q-P,REPL KIT, 1 ELECTRODE |
| 00883873824603 - CHARGE-PAK Charging Unit & 2 QUIK-PAK Electrodes | 2023-02-28 SHIPPING ASSY-C-P, Q-P,REPL KIT, 2 ELECTRODE |
| 00883873824610 - ELECTRODE ASSY-QUIK-COMBO | 2023-02-28 ELECTRODE ASSY-QUIK-COMBO QUIK-PAK,SET,WW |
| 00883873793497 - NA | 2020-12-10 LP1000 ASSEMBLY BATTERY REPLACEMENT KIT |