FDA 510(k) Applications Submitted by CARDINAL HEALTH 200, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160339 |
02/08/2016 |
Cardinal Health Isolation Gown |
Cardinal Health 200, LLC |
| K170762 |
03/13/2017 |
Cardinal Health Non-Reinforced Surgical Gown |
Cardinal Health 200, LLC |
| K200824 |
03/30/2020 |
Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown |
Cardinal Health 200, LLC |
| K182830 |
10/05/2018 |
Cardinal HealthTM Poly-Coated Open-Back Protective Gown |
Cardinal Health 200, LLC |
| K193327 |
12/02/2019 |
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve |
Cardinal Health 200, LLC |
| K192374 |
08/30/2019 |
Cardinal HealthÖ Level 3 Surgical Mask with Anti-Fog Foam Strip |
Cardinal Health 200, LLC |
| K230838 |
03/27/2023 |
Cardinal HealthÖ SmartGownÖ EDGE Breathable Surgical Gown with ASSISTÖ Instrument Pockets |
Cardinal Health 200, LLC |
| K223376 |
11/04/2022 |
Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) |
Cardinal Health 200, LLC |
| K140155 |
01/22/2014 |
SECURE-GARD SURGICAL AND PROCEDURE FACE MASK |
CARDINAL HEALTH 200, LLC |
| K130404 |
02/19/2013 |
TIBURON SURGICAL DRAPE |
CARDINAL HEALTH 200, LLC |
| K120658 |
03/05/2012 |
DURABLUE STERILIZATION WRAP |
CARDINAL HEALTH 200, LLC |
| K130927 |
04/03/2013 |
DURABLUE STERILIZATION WRAP |
CARDINAL HEALTH 200, LLC |
| K112211 |
08/02/2011 |
DURA BLUE STERILIZATION WRAP |
CARDINAL HEALTH 200, LLC |
| K112283 |
08/09/2011 |
DURA BLUE STERILIZATION WRAP |
CARDINAL HEALTH 200, LLC |
| K122507 |
08/17/2012 |
DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION |
CARDINAL HEALTH 200, LLC |
| K112918 |
10/03/2011 |
DURABLUE STERILIZATION (AMSCO V-PRO) WRAP |
CARDINAL HEALTH 200, LLC |
| K142990 |
10/16/2014 |
Insta-Gard Surgical and Procedure Face Mask |
Cardinal Health 200, LLC |
| K123857 |
12/14/2012 |
DURABLUE STERILIZATION WRAP |
CARDINAL HEALTH 200, LLC |
| K151445 |
05/29/2015 |
Cardinal Health Sterilization Wrap |
CARDINAL HEALTH 200, LLC |
| K151788 |
07/01/2015 |
Cardinal Health Sterilization Wrap |
Cardinal Health 200, LLC |
| K161910 |
07/12/2016 |
Cardinal Health Sterilization Wrap |
CARDINAL HEALTH 200, LLC |
| K201592 |
06/12/2020 |
Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove |
Cardinal Health 200, LLC |
| K211390 |
05/05/2021 |
Nitrile Blue Powder-free Examination Glove |
Cardinal Health 200, LLC |
|
|
