Device, Warming. Blood And Plasma

Product Code: KZL

Hematology Microwave Medical Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 864.9205


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as KZL

2409Device, Warming. Blood And PlasmaBlood And Plasma Warming Device.

Total Product Life Cycle (TPLC) Devices

2409Device, Warming. Blood And PlasmaBlood And Plasma Warming Device.

Pre-market Notifications for KZL

BK190401Blood And Plasma Warming DevicesFremon Scientific Inc
BK150301Blood And Plasma Warming DevicesBelmont Instrument Corporation
BK100063Blood And Plasma Warming DevicesBarkey GmbH & Co KG
BK100051Device, Warming, Blood And PlasmaBoekel Scientific, Inc
BK070055Blood And Plasma Warming DevicesThe Surgical Company International
BK050058Blood And Plasma Warming DevicesThe Surgical Company International
BK040080Blood And Plasma Warming DevicesSarstedt, Inc.
BK010045Blood And Plasma Warming DevicesSarstedt, Inc.
BK990018Device, Warming, Blood And PlasmaShotwell & Carr, Inc.
BK980042Blood And Plasma Warming DevicesCytoTherm LP
BK970045Blood And Plasma Warming DevicesMicrowave Medical System
BK970044Blood And Plasma Warming DevicesMicrowave Medical System
BK960075Blood And Plasma Warming DevicesMallinckrodt Medical, Inc.
BK960012Blood And Plasma Warming DevicesCytoTherm LP
BK950038Device, Warming, Blood And PlasmaDUPACO

Global Unique Device Identification Database

00695085800210DEVICE, WARMING. BLOOD AND PLASMA
00863626000201Device, Warming. Blood And Plasma
00861128000354Device, Warming. Blood And Plasma
00861128000347Device, Warming. Blood And Plasma
00861128000330Device, Warming. Blood And Plasma
00861128000323Device, Warming. Blood And Plasma
00861128000316Device, Warming. Blood And Plasma
00861128000309Device, Warming. Blood And Plasma
35019315057919DEVICE, WARMING. BLOOD AND PLASMA
04059201000018Device, Warming. Blood And Plasma
04059201000001Device, Warming. Blood And Plasma
50885380024847DEVICE, WARMING. BLOOD AND PLASMA
50707387781922DEVICE, WARMING. BLOOD AND PLASMA
50707387781380DEVICE, WARMING. BLOOD AND PLASMA
10695085403005DEVICE, WARMING. BLOOD AND PLASMA

Maude Adverse Events

LEVEL 1 NORMOTHERMIC IV FLUID ADMIN SETSMITHS MEDICAL ASD, INC.2020-03-26
LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETSSMITHS MEDICAL ASD, INC.2020-03-12
SMITHS MEDICAL LEVEL 1 TRAUMA FAST FLOW DISPOSABLESSMITHS MEDICAL ASD, INC.2020-02-26
LEVEL 1 HOTLINE ACCESSORIESSMITHS MEDICAL ASD; INC.2020-02-20
LEVEL 1? H-1200 FAST FLOW ACCESSORIESSMITHS MEDICAL ASD; INC.2020-02-20
LEVEL 1? FAST FLOW FLUID WARMER DISPOSABLESMITHS MEDICAL ASD; INC.2020-02-19
LEVEL 1 TRAUMA FAST FLOW DISPOSABLESSMITHS MEDICAL ASD, INC2020-02-17
LEVEL 1? HOTLINE? LOW FLOW SYSTEMSMITHS MEDICAL ASD; INC.2020-02-15
LEVEL 1 TRAUMA FAST FLOW DISPOSABLESSMITHS MEDICAL ASD; INC.2020-02-12
LEVEL 1 TRAUMA FAST FLOW DISPOSABLESSMITHS MEDICAL ASD; INC.2020-02-12
LEVEL 1 TRAUMA FAST FLOW DISPOSABLESSMITHS MEDICAL ASD; INC.2020-02-12
LEVEL 1 NORMOTHERMIC IV FLUID ADMIN SETSMITHS MEDICAL ASD, INC.2020-02-09
LEVEL 1? DISPOSABLE ACCESSORY2020-02-05
LEVEL 1? DISPOSABLE ACCESSORY2020-02-05
LEVEL 1 TRAUMA FAST FLOW DISPOSABLESMITHS MEDICAL ASD, INC2020-01-23
LEVEL 1? FAST FLOW FLUID DISPOSABLESMITHS MEDICAL ASD; INC.2020-01-21
LEVEL 1? FAST FLOW FLUID DISPOSABLESMITHS MEDICAL ASD; INC.2020-01-21
LEVEL 1 TRAUMA FAST FLOW DISPOSABLESMITHS MEDICAL ASD; INC.2019-11-01
SMITHS MEDICAL RAPID INFUSER (TUBING)SMITHS MEDICAL ASD, INC.2019-09-05
RANGER 2453M COMPANY2018-09-12
LEVEL 1SMITHS MEDICAL MD, INC.2018-09-11
LEVEL 1 NORMOTHERMIC IV FLUID ADMINISTRATION SETSMITHS HEALTHCARE2018-01-10
LEVEL 1? DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETSMITHS MEDICAL ASD, INC.2017-12-21
LEVEL 1? DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETSMITHS MEDICAL ASD, INC.2017-12-21
LEVEL 1? DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETSMITHS MEDICAL ASD, INC.2017-12-21
3M RANGER3M COMPANY2017-03-06
LEVEL 1? DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETSSMITHS MEDICAL ASD, INC.2017-02-08
LEVEL 1? FAST FLOW FLUID WARMER DISPOSABLE ADMINISTRATION SETSSMITHS MEDICAL ASD, INC.2016-11-03
LEVEL 1? DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETSMITHS MEDICAL ASD, INC.2016-11-01
LEVEL 1? BLOOD-FLUID ADMINISTRATION SETSMITHS MEDICAL ASD INC.2016-08-02
LEVEL 1 ? DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETSSMITHS HEALTHCARE MFG2016-07-21
LEVEL 1? DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS ADD TO INQUIRY ADD TOSMITHS MEDICAL ASD INC.,2016-02-26
CAPITAL BLOOD/FLUID WARMERSTRYKER MEDICAL-KALAMAZOO2016-02-10
CAPITAL BLOOD/FLUID WARMERSTRYKER MEDICAL-KALAMAZOO2016-02-10
CAPITAL BLOOD/FLUID WARMERSTRYKER MEDICAL-KALAMAZOO2016-02-04
CAPITAL BLOOD/FLUID WARMERSTRYKER MEDICAL-KALAMAZOO2016-02-03
CAPITAL BLOOD/FLUID WARMERSTRYKER MEDICAL-KALAMAZOO2016-02-03
CAPITAL BLOOD/FLUID WARMERSTRYKER MEDICAL-KALAMAZOO2015-12-15
B/F WARM SET HIGH FLOW CESTRYKER MEDICAL-KALAMAZOO2015-12-15
CAPITAL BLOOD/FLUID WARMERSTRYKER MEDICAL-KALAMAZOO2015-09-25
CAPITAL BLOOD/FLUID WARMERSTRYKER MEDICAL-KALAMAZOO2015-08-14
LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETSMITHS MEDICAL ASD, INC.,2015-08-11
B/F WARM SET HIGH FLOW CESTRYKER MEDICAL-KALAMAZOO2015-07-10
B/F WARM SET HIGH FLOW CESTRYKER MEDICAL-KALAMAZOO2015-07-10
B/F WARM SET HIGH FLOW CESTRYKER MEDICAL-KALAMAZOO2015-07-10
B/F WARM SET HIGH FLOW CESTRYKER MEDICAL-KALAMAZOO2015-07-10
B/F WARM SET HIGH FLOW CESTRYKER MEDICAL-KALAMAZOO2015-07-10
LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETSMITHS MEDICAL ASD, INC.2015-07-10
B/F WARM SET HIGH FLOW CESTRYKER MEDICAL-KALAMAZOO2015-07-10
LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETSMITHS MEDICAL ASD, INC.2015-07-08

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