FDA.reportPublic FDA data

Medical Action Industries

Primary DI
20809160009496
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
59030
Device description
Kit: CVC Maximum Barrier 12/Cs
Published
2016-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
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
20809160009496PackageGS112In Commercial Distribution
10809160009499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916000949620809160009496
1080916000949910809160009499

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterization kit, short-termA collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160521748MEDICAL ACTION INDUSTRIES849572026-05-22
10809160433560Medical Action Industries838852024-08-23
10809160278833Medical Action Industries78898D2020-02-21
10809160107270MEDICAL ACTION INDUSTRIES807792016-09-27
10809160188736Medical Action Industries781402018-04-13
10809160220733Medical Action Industries78521B2018-12-11
10809160272022Medical Action Industries789572019-11-21
10809160521410MEDICAL ACTION INDUSTRIES848532026-05-15
10809160521427MEDICAL ACTION INDUSTRIES848572026-05-15
10809160521434MEDICAL ACTION INDUSTRIES81183F2026-05-15
10809160521441Medical Action Industries81183E2026-05-15
10809160168493Medical Action Industries76828B2017-10-27
10809160520925MEDICAL ACTION INDUSTRIES847172026-05-11
10809160345108Medical Action Industries80391B2021-02-05
10809160429389Medical Action Industries840862024-07-10
10809160520635Medical Action Industries83349B2026-05-07
10809160520468Medical Action Industries771202026-05-05
10809160016770Medical Action Industries718912016-08-20
10809160394052Medical Action Industries833482023-02-09
10809160435038Medical Action Industries838262024-09-06

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
10809160365939Therma SolutionsMEDICAL ACTION INDUSTRIES INC.OKH2022-02-16
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