FDA.reportPublic FDA data

MEDLINE

Primary DI
10193489099560
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
1202YLWOS
Catalog number
1202YLWOS
Device description
LEVEL 2, ISO GOWN, NO CARBON, OSFM
Published
2024-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEANon-surgical gown

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30193489099564PackageGS172In Commercial Distribution
10193489099560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3019348909956430193489099564
1019348909956010193489099560

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, reusableA 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 reusable garment intended to be laundered after each use.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888277417205MEDLINEMSG9460MSG94602026-08-03
10888277417212MEDLINEMSG9465MSG94652026-08-03
10888277417229MEDLINEMSG9470MSG94702026-08-03
10888277417236MEDLINEMSG9475MSG94752026-08-03
10888277417243MEDLINEMSG9480MSG94802026-08-03
10888277417250MEDLINEMSG9485MSG94852026-08-03
10888277417267MEDLINEMSG9490MSG94902026-08-03
10888277603516MEDLINEMSG9590MSG95902026-08-03
20197344102898GeminiGEM3120CGEM3120C2024-08-02
20197344102904GeminiGEM3120SCGEM3120SC2024-07-15
10080196184125GeminiGEM3120SGEM3120S2016-10-14
10080196184286MEDLINEGEM3130SGEM3130S2016-10-14
10197344169405MEDLINEMSCSRG9636MSCSRG96362026-07-31
10198459678653MEDLINEURO175806PSURO175806PS2026-07-31
10198459678660MEDLINEURO175808PSURO175808PS2026-07-31
10198459678677MEDLINEURO175806SURO175806S2026-07-31
10198459678684MEDLINEURO175808SURO175808S2026-07-31
10198459678691MEDLINEURO175810SURO175810S2026-07-31
10198459679025MEDLINEURO175810PSURO175810PS2026-07-31
20197344219237MEDLINENON27393NON273932026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
50080196247576MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50193489109885MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50193489109892MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40884389804637MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-17
50193489108239MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-17
40080196772026MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-03
00199536901001BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901018BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901308BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901315BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901407BluelineTransparent Supply Solutions Ltd.OEA2026-05-15