| MDS |
Sensor, Glucose, Invasive |
Unknown |
Class 3 |
N/A
|
2013-11-08 |
| OZO |
Automated Insulin Dosing , Threshold Suspend |
Unknown |
Class 3 |
N/A
|
2013-11-08 |
| QFG |
Alternate Controller Enabled Insulin Infusion Pump |
Clinical Chemistry |
Class 2 |
880.5730
|
2025-09-25 |
| NDC |
Calculator, Drug Dose |
Anesthesiology |
Class 2 |
868.1890
|
2025-09-25 |
| PKU |
Insulin Pump Secondary Display |
Clinical Chemistry |
Class 2 |
862.1350
|
2015-08-26 |
| PJT |
Continuous Glucose Monitor Secondary Display |
Clinical Chemistry |
Class 2 |
862.1350
|
2015-08-26 |
| FPA |
Set, Administration, Intravascular |
General Hospital |
Class 2 |
880.5440
|
2016-08-09 |
| FMF |
Syringe, Piston |
General Hospital |
Class 2 |
880.5860
|
2021-06-02 |
| MDS |
Sensor, Glucose, Invasive |
Unknown |
Class 3 |
N/A
|
2016-04-06 |
| OYC |
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor |
Unknown |
Class 3 |
N/A
|
2016-04-06 |
| QFG |
Alternate Controller Enabled Insulin Infusion Pump |
Clinical Chemistry |
Class 2 |
880.5730
|
2026-03-20 |
| NDC |
Calculator, Drug Dose |
Anesthesiology |
Class 2 |
868.1890
|
2026-02-19 |
| SFI |
Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System |
Unknown |
Class 3 |
N/A
|
2025-08-08 |
| KZH |
Introducer, Syringe Needle |
General Hospital |
Class 2 |
880.6920
|
2013-03-27 |
| FPA |
Set, Administration, Intravascular |
General Hospital |
Class 2 |
880.5440
|
2016-08-09 |
| OUG |
Medical Device Data System |
General Hospital |
Class 1 |
880.6310
|
2025-12-04 |
| FPA |
Set, Administration, Intravascular |
General Hospital |
Class 2 |
880.5440
|
2016-08-09 |
| FPK |
Tubing, Fluid Delivery |
General Hospital |
Class 2 |
880.5440
|
2016-08-09 |
| KZH |
Introducer, Syringe Needle |
General Hospital |
Class 2 |
880.6920
|
2016-10-20 |
| FRN |
Pump, Infusion |
General Hospital |
Class 2 |
880.5725
|
2025-11-24 |
| OZP |
Automated Insulin Dosing Device System, Single Hormonal Control |
Unknown |
Class 3 |
N/A
|
2016-10-20 |
| FPA |
Set, Administration, Intravascular |
General Hospital |
Class 2 |
880.5440
|
2016-08-09 |
| OZO |
Automated Insulin Dosing , Threshold Suspend |
Unknown |
Class 3 |
N/A
|
2021-12-23 |
| FPA |
Set, Administration, Intravascular |
General Hospital |
Class 2 |
880.5440
|
2014-10-31 |
| NDC |
Calculator, Drug Dose |
Anesthesiology |
Class 2 |
868.1890
|
2021-06-02 |
| FMF |
Syringe, Piston |
General Hospital |
Class 2 |
880.5860
|
2021-06-02 |
| FMF |
Syringe, Piston |
General Hospital |
Class 2 |
880.5860
|
2021-06-02 |
| NDC |
Calculator, Drug Dose |
Anesthesiology |
Class 2 |
868.1890
|
2021-06-02 |
| OZO |
Automated Insulin Dosing , Threshold Suspend |
Unknown |
Class 3 |
N/A
|
2016-08-15 |
| FPA |
Set, Administration, Intravascular |
General Hospital |
Class 2 |
880.5440
|
2013-03-27 |
| FPK |
Tubing, Fluid Delivery |
General Hospital |
Class 2 |
880.5440
|
2013-03-27 |
| KZH |
Introducer, Syringe Needle |
General Hospital |
Class 2 |
880.6920
|
2013-03-27 |
| MRZ |
Accessories, Pump, Infusion |
General Hospital |
Class 2 |
880.5725
|
2013-03-27 |
| MDS |
Sensor, Glucose, Invasive |
Unknown |
Class 3 |
N/A
|
2013-03-27 |
| LZG |
Pump, Infusion, Insulin |
General Hospital |
Class 2 |
880.5725
|
2005-07-26 |
| FPA |
Set, Administration, Intravascular |
General Hospital |
Class 2 |
880.5440
|
2021-06-10 |
| FRN |
Pump, Infusion |
General Hospital |
Class 2 |
880.5725
|
2013-01-29 |
| KZH |
Introducer, Syringe Needle |
General Hospital |
Class 2 |
880.6920
|
2013-03-27 |
| LZG |
Pump, Infusion, Insulin |
General Hospital |
Class 2 |
880.5725
|
2022-05-16 |
| LZG |
Pump, Infusion, Insulin |
General Hospital |
Class 2 |
880.5725
|
2013-03-27 |
| MDS |
Sensor, Glucose, Invasive |
Unknown |
Class 3 |
N/A
|
2016-09-07 |
| OZO |
Automated Insulin Dosing , Threshold Suspend |
Unknown |
Class 3 |
N/A
|
2016-09-07 |
| MDS |
Sensor, Glucose, Invasive |
Unknown |
Class 3 |
N/A
|
2018-03-20 |
| OZP |
Automated Insulin Dosing Device System, Single Hormonal Control |
Unknown |
Class 3 |
N/A
|
2018-03-20 |
| PQF |
Sensor, Glucose, Invasive, Non-Adjunctive |
Unknown |
Class 3 |
N/A
|
2018-03-20 |
| OZP |
Automated Insulin Dosing Device System, Single Hormonal Control |
Unknown |
Class 3 |
N/A
|
2021-06-08 |
| QJS |
Interoperable Automated Glycemic Controller, Insulin Suspend |
Clinical Chemistry |
Class 2 |
862.1356
|
2026-03-25 |
| QJI |
Interoperable Automated Glycemic Controller |
Clinical Chemistry |
Class 2 |
862.1356
|
2026-03-25 |
| NDC |
Calculator, Drug Dose |
Anesthesiology |
Class 2 |
868.1890
|
2026-03-25 |
| QJI |
Interoperable Automated Glycemic Controller |
Clinical Chemistry |
Class 2 |
862.1356
|
2026-03-20 |
| QJS |
Interoperable Automated Glycemic Controller, Insulin Suspend |
Clinical Chemistry |
Class 2 |
862.1356
|
2026-03-20 |
| FPA |
Set, Administration, Intravascular |
General Hospital |
Class 2 |
880.5440
|
2016-08-09 |
| PHV |
Continuous Glucose Monitor Retrospective Data Analysis Software |
Clinical Chemistry |
Class 1 |
862.2120
|
2015-08-20 |
| OYC |
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor |
Unknown |
Class 3 |
N/A
|
2007-12-06 |
| MDS |
Sensor, Glucose, Invasive |
Unknown |
Class 3 |
N/A
|
2007-12-06 |
| NDC |
Calculator, Drug Dose |
Anesthesiology |
Class 2 |
868.1890
|
2021-06-02 |
| CGA |
Glucose Oxidase, Glucose |
Clinical Chemistry |
Class 2 |
862.1345
|
2014-10-31 |
| QFG |
Alternate Controller Enabled Insulin Infusion Pump |
Clinical Chemistry |
Class 2 |
880.5730
|
2026-03-20 |
| FRN |
Pump, Infusion |
General Hospital |
Class 2 |
880.5725
|
2013-01-29 |
| FRN |
Pump, Infusion |
General Hospital |
Class 2 |
880.5725
|
2013-03-27 |
| LZG |
Pump, Infusion, Insulin |
General Hospital |
Class 2 |
880.5725
|
2013-03-27 |
| LZG |
Pump, Infusion, Insulin |
General Hospital |
Class 2 |
880.5725
|
2013-03-27 |
| KGX |
Tape And Bandage, Adhesive |
General Hospital |
Class 1 |
880.5240
|
2025-12-03 |