| Primary Device ID | M752TMCLK15 |
| NIH Device Record Key | ff46c45d-b848-45a5-a0d8-3465d0abbf1f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stradis Medical, LLC |
| Version Model Number | TMCLK-1 |
| Company DUNS | 043537671 |
| Company Name | STRADIS MEDICAL LLC |
| 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 | true |
| 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 |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com | |
| Phone | 1-800-424-8520 |
| cs@stradishealthcare.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M752TMCLK10 [Primary] |
| HIBCC | M752TMCLK15 [Package] Contains: M752TMCLK10 Package: outer box [30 Units] In Commercial Distribution |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-06-19 |
| Device Publish Date | 2019-12-23 |
| M752MM8515CP25 | Central Line Dressing Change Tray |
| M752HCT847325 | Dressing Change Tray |
| M752IM12655 | Dressing Change Kit with SorbaView |
| M752TM882315 | Port Access Tray |
| M752SXPOUCH5 | Surgery Prep & Recovery Kit |
| M752IM12646 | Hazardous Drug Spill Kit |
| M752TM882316 | Port Access Tray |
| M752IM22015 | IV START KIT W/CHLORAPREP, GEN |
| M752COTA81385 | Explant Kit |
| M752COTA81365 | Implant Kit |
| M752HCT35485 | 12CC SYRINGE KIT |
| M752TM9966NGND0 | PICC Insertion Tray |
| M752TM996620 | PICC Insertion Tray |
| M752CPD20003 | Catheter Securement Device |
| M752HCT20500 | 50mL EVA Bags, 2 Port |
| M752HCT201006 | 100mL EVA Bags, 2 Port |
| M752HCT105006 | 500mL EVA Bags, 2 Port |
| M752HCT43320 | 60CC SYRINGE KIT |
| M752HCT100GD20 | CENTRAL LINE KIT 4MM |
| M752HCT6186CP15 | Prep Kit |
| M752HCT541BP2A5 | Central Line Kit |
| M752TSBRF6645 | TROCAR KIT 4.5MM |
| M752TSBRF6630 | TROCAR KIT 3.5MM |
| M752TM9538CS0 | PORT PICC ACCESS TRAY |
| M7521000415 | NIMBUS II START OF CARE KIT |
| M752DC5605 | Dressing Change Tray |
| M752RWM69KCLYS0 | Hypodermoclysis Kit |
| M752TMFFTK5 | FLUID FILTER TRANSFER KIT |
| M752HCT6868PA3NG5 | Port Access Tray without gloves |
| M752TMCLK25 | Central Line Kit |
| M752DC560A0 | Dressing Change Tray |
| M752ZZ09585 | Surgical Suture Kit |
| M752HCT354822 | 12CC SYRINGE KIT |
| M752RWM69KTA015 | DRESSING CHANGE TRAY W/CHLOR ONE-STEP, TEGADERM, STATLOCK AND DRESSING |
| M752HCT200GDBP5 | DIALYSIS/CORDIS DRESSING CHANGE KIT BIOPATCH |
| M752DC8903CP25 | Dressing Change Tray |
| M752CD22005 | Dressing Change Kit |
| M752TMCLK15 | Central Line Kit |