| Primary Device ID | H787MRC3RD0041 | 
| NIH Device Record Key | 10e8e493-fe88-4bfc-9b3e-a92901011189 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | C3 WAVE SYSTEM | 
| Version Model Number | MRC3RD004 | 
| Company DUNS | 079105071 | 
| Company Name | ANGIODYNAMICS, 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 | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 | 
| dgreer@angiodynamics.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | H787MRC3RD0041 [Primary] | 
| LJS | Catheter, intravascular, therapeutic, long-term greater than 30 days | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-04-18 | 
| Device Publish Date | 2022-04-08 | 
| 15051684020862 | C3 ECG SYSTEM - US | 
| 15051684020855 | C3 ECG SYSTEM W/ IPAD - US | 
| 15051684027397 | C3 WAVE REMOTE BATTERY ACC | 
| 15051684027380 | C3 WAVE HUB CHARGING BASE ACC | 
| 15051684027373 | C3 WAVE IPAD CASE ACCESSORY | 
| 15051684027366 | C3 WAVE QUICK RELEASE CLAMP | 
| 15051684027359 | BROTHER LABEL PRINTER | 
| 15051684027328 | C3 WAVE ECG LEAD SET (IEC) | 
| 15051684027311 | C3 WAVE HUB BATTERY ACCESSORY | 
| 15051684027274 | C3 POLE MOUNT KIT | 
| 15051684027267 | C3 WAVE CASE | 
| 15051684027243 | C3 WAVE REMOTE ACCESSORY | 
| 15051684027236 | C3 WAVE HUB ACCESSORY | 
| H787MRC3RD0041 | C3 ECG CABLE ACCESSORY PACK W/MB DRAPE - US | 
| H787MRC3RD0031 | C3 ACCESSORY PACK (REMOTE CVR & CLIP/CABLE) - US | 
| H787MRC3RD0001 | C3 ECG CABLE ACCESSORY PACK - US | 
| 15051684027199 | C3 ACCESSORY PACK (REMOTE CVR & CLIP/CABLE) | 
| 15051684027168 | C3 ECG CABLE ACCESSORY PACK |