FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
20080196765499
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
NONLV325XL
Catalog number
NONLV325XL
Device description
GOWN,ISO,LVL3,SMS,KNITCUFF,HOOKLP,BLU,XL
Published
2020-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYCGown, isolation, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYCGown, Isolation, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196765493PackageGS15In Commercial Distribution
20080196765499PrimaryGS10
10080196765492Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019676549340080196765493
2008019676549920080196765499
1008019676549210080196765492

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
10
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813360021475ProtexerICP MEDICAL, LLCFYC2025-08-15
10813360021472ProtexerICP MEDICAL, LLCFYC2025-08-15
00813360021468ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162000030ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162290004ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162390506ProtexerICP MEDICAL, LLCFYC2025-08-08
10813360021465ProtexerICP MEDICAL, LLCFYC2025-08-08
00813360021772ProtexerICP MEDICAL, LLCFYC2025-08-08
00842942015175PRIMEDpriMED Medical Products IncFYC2025-07-21
00842942015304PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015172PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015301PRIMEDpriMED Medical Products IncFYC2025-07-21
04719882251399CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251412CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251436CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251450CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251559CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251573CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251597CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251610CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251719CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251733CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251757CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251771CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251396CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251419CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251433CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251457CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251556CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251570CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16