FDA.reportPublic FDA data

Therma Solutions

Primary DI
10809160365939
Brand
Therma Solutions
Company
MEDICAL ACTION INDUSTRIES INC.
Model
ANC-3500
Published
2022-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OKHBody fluids barrier kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKHBody Fluids Barrier KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160365936PackageGS110In Commercial Distribution
10809160365939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916036593620809160365936
1080916036593910809160365939

GMDN Terms#

Term, Definition table
TermDefinition
Cytotoxic material spill kitA set of devices used to clean up spillage of cytotoxic material. It provides equipment and material for an appropriate method for removing the spillage, and includes the proper container for the disposal of the spillage. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160527665MEDICAL ACTION INDUSTRIES849602026-07-21
10809160527054Medical Action Industries78216C2026-07-14
10809160527078MEDICAL ACTION INDUSTRIES848842026-07-14
10809160527030MEDICAL ACTION INDUSTRIES848882026-07-13
10809160526866MEDICAL ACTION INDUSTRIES850202026-07-08
10809160526873MEDICAL ACTION INDUSTRIES849172026-07-08
10809160526750MEDICAL ACTION INDUSTRIES851662026-07-06
10809160526774HALYARD849182026-07-06
10809160526781HALYARD849162026-07-06
10809160231869Medical Action IndustriesLH_71171B2019-03-20
10809160476505Medical Action Industries843102025-07-09
10809160523155MEDICAL ACTION INDUSTRIES850142026-06-09
10809160226100Splash Medical Devices715622019-02-05
10809160522790Medical Action Industries851072026-06-05
10809160522806Medical Action Industries851642026-06-05
10809160522479Medical Action Industries848692026-06-03
10809160521748MEDICAL ACTION INDUSTRIES849572026-05-22
10809160433560Medical Action Industries838852024-08-23
10809160278833Medical Action Industries78898D2020-02-21
10809160107270MEDICAL ACTION INDUSTRIES807792016-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160388990Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2022-11-09
20809160388997Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2022-11-09
20809160365936Therma SolutionsMEDICAL ACTION INDUSTRIES INC.OKH2022-02-16
00810071632402CuraplexBOUND TREE MEDICAL, LLCOKH2021-09-30
00749756915618DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-08-23
50749756915613DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-08-23
00749756201070DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-07-12
50749756201075DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-07-12
15060498452158Motion Medical DistributingHaslam Medical, Inc.OKH2021-02-15
25060498452155Motion Medical DistributingHaslam Medical, Inc.OKH2021-02-15
15060498452097Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
15060498452103Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
15060498452110Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
15060498452127Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
25060498452094Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
25060498452100Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
25060498452117Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
25060498452124Motion Medical DistributingHaslam Medical, Inc.OKH2020-12-04
10809160274033Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-12-13
20809160274030Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-12-13
10809160272589Medical Action Industries IncMEDICAL ACTION INDUSTRIES INC.OKH2019-11-22
10809160269091medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-11-01
20809160269098medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-11-01
10809160267028Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-10-16
20809160267025Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-10-16
10809160266885HalyardMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
10809160266892HALYARDMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
20809160266882HalyardMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
20809160266899HALYARDMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
10809160261897Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-09-16