FDA.reportPublic FDA data

MEDICAL ACTION INDUSTRIES

Primary DI
20809160001025
Brand
MEDICAL ACTION INDUSTRIES
Company
MEDICAL ACTION INDUSTRIES INC.
Model
70793
Published
2016-08-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
20809160001025PackageGS120Not in Commercial Distribution
10809160001028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916000102520809160001025
1080916000102810809160001028

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
true
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
20809160517113MEDICAL ACTION INDUSTRIES843992026-03-23
20809160516574Medical Action Industries82274B2026-03-19
20809160016463Medical Action Industries716912016-08-20
20809160515195Clear Sequence836992026-03-06
20809160515218MEDICAL ACTION INDUSTRIES848602026-03-06
20809160515157MEDICAL ACTION INDUSTRIES847242026-03-05
20809160514938Medical Action Industries81329E2026-03-04
20809160514990Medical Action Industries76567F2026-03-04
20809160515003Medical Action Industries78304B2026-03-04
20809160515027Medical Action Industries77156B2026-03-04
20809160514754MEDICAL ACTION INDUSTRIES82438B2026-03-03
20809160514761MEDICAL ACTION INDUSTRIES82436B2026-03-03
20809160514136Medical Action Industries837402026-02-26
20809160513856Medical Action Industries822742026-02-25
20809160513924MEDICAL ACTION INDUSTRIES848192026-02-25
20809160513337MEDICAL ACTION INDUSTRIES82274C2026-02-20
20809160512521MEDICAL ACTION INDUSTRIES826092026-02-13
20809160512231MEDICAL ACTION INDUSTRIES846012026-02-11
20809160512248MEDICAL ACTION INDUSTRIES843142026-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20809160388997Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2022-11-09
20809160365936Therma SolutionsMEDICAL ACTION INDUSTRIES INC.OKH2022-02-16
50749756915613DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-08-23
50749756201075DeRoyalDEROYAL INDUSTRIES, INC.OKH2021-07-12
25060498452155Motion Medical DistributingHaslam Medical, Inc.OKH2021-02-15
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
20809160274030Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-12-13
20809160269098medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-11-01
20809160267025Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-10-16
20809160266882HalyardMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
20809160266899HALYARDMEDICAL ACTION INDUSTRIES INC.OKH2019-10-14
20809160261894Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2019-09-16
00815277028790CuraplexBOUND TREE MEDICAL, LLCOKH2018-12-15
00815277029544CuraplexBOUND TREE MEDICAL, LLCOKH2018-12-15
00815277029551CuraplexBOUND TREE MEDICAL, LLCOKH2018-12-15
00817617028675CuraplexBOUND TREE MEDICAL, LLCOKH2017-10-13
00817617028682CuraplexBOUND TREE MEDICAL, LLCOKH2017-10-13
00817617028699CuraplexBOUND TREE MEDICAL, LLCOKH2017-10-13
00817617028705CuraplexBOUND TREE MEDICAL, LLCOKH2017-10-13
20809160165871Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2017-10-09
00817617027722CuraplexBOUND TREE MEDICAL, LLCOKH2017-07-27
25060498451547Motion Medical DistributingHaslam Medical, Inc.OKH2017-06-13
25060498451516Motion Medical DistributingHaslam Medical, Inc.OKH2017-06-06
25060498451523Motion Medical DistributingHaslam Medical, Inc.OKH2017-06-06
20809160145484Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OKH2017-04-21
25060498451349Motion Medical DistributingHaslam Medical, Inc.OKH2017-02-28
00815277020077CuraplexBOUND TREE MEDICAL, LLCOKH2016-12-14