FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
30080196765496
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
NONLV325XL
Catalog number
NONLV325XL
Device description
GOWN,ISO,KNITCUFF, PREMIUM BLUE, LV3,XL
Published
2020-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
20080196765499PackageGS110In Commercial Distribution
30080196765496PackageGS110In Commercial Distribution
40080196765493PackageGS150In Commercial Distribution
10080196765492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2008019676549920080196765499
3008019676549630080196765496
4008019676549340080196765493
1008019676549210080196765492

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813360021472ProtexerICP MEDICAL, LLCFYC2025-08-15
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
10842942015172PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015301PRIMEDpriMED Medical Products IncFYC2025-07-21
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
14719882251594CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251617CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251716CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251730CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251754CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251778CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
10842942008297PRIMEDpriMED Medical Products IncFYC2025-07-15
10842942008303PRIMEDpriMED Medical Products IncFYC2025-07-15
10842942008457PRIMEDpriMED Medical Products IncFYC2025-07-15
10842942008464PRIMEDpriMED Medical Products IncFYC2025-07-15
10842942011044PRIMEDpriMED Medical Products IncFYC2025-07-15
10842942011785PRIMEDpriMED Medical Products IncFYC2025-07-15
00850061262196Resilient Medical SolutionsResilient Medical Solutions, LLCFYC2025-03-17
00850061262257Resilient Medical SolutionsResilient Medical Solutions, LLCFYC2025-03-17
00810101310102PaneffortPaneffort, LLCFYC2024-12-18
00810101310331PaneffortPaneffort, LLCFYC2024-12-18