| Primary Device ID | M752TM99615 |
| NIH Device Record Key | bc5de22a-af89-4498-b91e-2e0b5def570e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stradis Medical, LLC. |
| Version Model Number | TM9966-1 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M752TM99615 [Package] Contains: M752TM996611 Package: outer box [10 Units] In Commercial Distribution |
| HIBCC | M752TM996611 [Primary] |
| OWL | Peripheral Catheter Insertion Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-09 |
| Device Publish Date | 2019-07-09 |
| M752IM1253A5 | Dressing Change Tray W/ GIVA |
| M752BRF236MSP18035 | Central Line Dressing Change Tray |
| M7529992814675 | ANA Kit |
| M752IV11346850 | IV Start Kit W/Chlorhexidine |
| M75211346855 | Patient Admin Kit |
| M752ACC26005 | MAX BARRIER PICC TRAY |
| M752TM99615 | PICC Insertion Tray |
| M752HCT8874VA25 | VAD ACCESS KIT |
| M752HCT5525PX20 | IV START KIT W/PREVAHEX |
| M752TM85165 | USG PERIPHERAL INSERTION KIT |
| M752HCT7478PIV5 | Ultrasound Guided PIV Kit |
| M752HCT7478PIV15 | ULTRASOUND GUIDED PIV KIT |
| M752IM12665 | Dressing Change Tray |
| M752ACC2500NG5 | PICC Line Insertion Tray |
| M752HCT9948BP15 | Dressing Change Tray W/ Biopatch |
| M752HCT5040CHG10 | Dressing Change Tray |
| M75220099SSHP0 | STANDARD HYGIENE PACK |
| M752UPC502M5 | PERSONAL PROTECTION EQUIPMENT PACK |
| M752UPC502L5 | PERSONAL PROTECTION EQUIPMENT PACK |
| M752SUBIMHYP10005 | HYPODERMOCLYSIS PREP KIT |
| M752IMHYP10005 | Hypodermoclysis Kit |
| M752HCT7478PIV1A5 | ULTRASOUND GUIDED PIV KIT W/ HAND SANITIZER |
| M752HCT6057CP10 | Central Line Discontinuation Kit |
| M752HCT900AGD15 | Arterial line Dressing Change Kit - GUARDIVA 4MM |
| M752TMBRF5945 | LVAD TRAY ( LEFT VENTRICULAR ASSIST DEVICE TRAY) |
| M752HHSBRF6610 | Dressing Kit |
| M752HCT8275CPB5 | Dressing Change Kit W/CHG |
| M752HCT6625CTA0 | TUFTS Central line Dressing Change Kit |
| M752HCT200GD25 | DIALYSIS/CORDIS DRESSING CHANGE KIT-GUARDIVA |
| M752DC1790925 | PICC / Midline Tray |
| M752HCTBBD1000 | SYRINGE CAPS |
| M752MSDC0109565 | DRESSING CHANGE TRAY W/CHG |
| M752HCT8249CP35 | Central Line Insertion Tray |
| M752HCT59750KA5 | Oncology Stop Kit |
| M752HCT2121CP15 | IV Start Kit |
| M752ACC2550NG5 | PICC KIT |
| M752HCT3058XCL5 | Dressing Change Tray with Antimicrobial Dressing |
| M752HCT8249CP3B5 | Child's Central Line Insertion Tray |
| M752TM85175 | USG PERIPHERAL INSERTION KIT |
| M752HCT1212SB5 | Dressing Change Tray W/ Biopatch |
| M7525113905 | Pen Needle Kit |
| M7525113890 | Pen Needle Kit |
| M752HCT1313B5 | Dressing Port Kit W/ Biopatch |
| M752HCT5040CHG1VG0 | Dressing Change Tray |
| M752HCT9948BP1VG5 | Dressing Change Tray W/ Biopatch |
| M752WC2505 | NOSE/MOUTH PAK |
| M752HCT984915 | Ultrasound Procedure Kit |
| M752HCT8428CP25 | MAX BARRIER PICC INSERTION TRAY |
| M752HCT7478PIV2A5 | Ultrasound Guided PIV Kit |
| M752HCT5975OKB0 | Oncology Stop Kit |