FDA.reportPublic FDA data

AMG

Primary DI
00850017650299
Brand
AMG
Company
ARROW MEDSOURCE GROUP LIMITED
Model
JSW-CA45SMS04
Device description
COVERALL ANTI-STATIC, WHITE, 45g SMS, XL
Published
2020-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850017650296PackageGS150In Commercial Distribution
00850017650299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001765029610850017650296
00850017650299008500176502998500176502990850017650299

GMDN Terms#

Term, Definition table
TermDefinition
Assistive coverallA lightweight wrap (e.g., made of vinyl, nylon, or other plastic) specially designed/adapted to be used by a person with a disability to cover and protect them against precipitation (rain, snow, sleet), cold and wind, especially when using a wheelchair, pram, or sledge. The device is typically hooded and has openings to allow access to the operating and steering controls of the occupied transportation device if required.

Regulatory Flags#

DUNS number
686378503
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810069260327AMG9500-N952021-01-27
00850017650305AMGBCPB001XL2020-06-22
00850017650343AMGBCRW001XL2020-06-22
00850017650671AMGSCP00012020-08-06
00810069260358AMG60022021-03-08
00810069260365AMG60032021-03-09
00810069260372AMG60112021-03-09
00810069260389AMG60122021-03-09
00810069260396AMG60132021-03-09
00810069260341AMG60012021-03-09
00810069260402AMG20112021-05-14
00810069260419AMG20122021-05-14
00810069260426AMG20132021-05-14
00810069260433AMG20142021-05-14
00810069260440AMG20152021-05-14
00810069260457AMG20162021-05-14
10810069260409AMG20112021-05-14
10810069260416AMG20122021-05-14
10810069260423AMG20132021-05-14
10810069260430AMG20142021-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344158895MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158918MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158932MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158956MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158970MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344158987MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344159014MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
20197344159106MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
40080196247616MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
40080196730248MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-08-18
00688162000764ProtexterICP MEDICAL, LLCOEA2026-08-05
00840118617567Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617581Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617604Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617628Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617659ENDURE INDUSTRIESENDURE INDUSTRIESOEA2026-08-03
00840118617673Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617697Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617710Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617741Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617772Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617802Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118687690Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118698399Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
30193489103964MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-28
30193489103971MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-28
30193489104893MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489107969MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120241MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120258MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24