FDA.report

Medical Action Industries

Primary DI
20809160145484
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
76827
Published
2017-04-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OKHBody fluids barrier kit

Product Code Classifications

CodeDeviceSpecialtyClass
OKHBody Fluids Barrier KitGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160145484PackageGS110Not in Commercial Distribution
10809160145487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916014548420809160145484
1080916014548710809160145487

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Sterilization Methods

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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20809160514136Medical Action Industries837402026-02-26
20809160513856Medical Action Industries822742026-02-25
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20809160513337MEDICAL ACTION INDUSTRIES82274C2026-02-20
20809160512521MEDICAL ACTION INDUSTRIES826092026-02-13
20809160512231MEDICAL ACTION INDUSTRIES846012026-02-11
20809160512248MEDICAL ACTION INDUSTRIES843142026-02-11
20809160512255MEDICAL ACTION INDUSTRIES846262026-02-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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25060498452155Motion Medical DistributingHaslam Medical, Inc.OKH2021-02-15
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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
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00815277029551CuraplexBOUND TREE MEDICAL, LLCOKH2018-12-15
00817617028675CuraplexBOUND TREE MEDICAL, LLCOKH2017-10-13
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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
25060498451349Motion Medical DistributingHaslam Medical, Inc.OKH2017-02-28
00815277020077CuraplexBOUND TREE MEDICAL, LLCOKH2016-12-14
00815277020169CuraplexBOUND TREE MEDICAL, LLCOKH2016-12-14