FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
10884389144640
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
NONCVP2XXXL
Catalog number
NONCVP2XXXL
Device description
COVERALL,PROHIBIT,ELSTCWRST/ANKL,WH, 3XL
Published
2022-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXOSUIT, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXOSuit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884389144641PrimaryGS10
10884389144640Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088438914464140884389144641
1088438914464010884389144640

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
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10884389177686MEDLINEMDSMPHS4MDSMPHS42021-04-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10097604599921Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2025-09-10
00889813060179Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
00889813060186Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
00889813060193Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060176Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060183Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060190Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
06921340881118customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340882115customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340883112customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340884119customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340885116customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340881115customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340882112customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340883119customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340884116customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340885113customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06973635612013MaoshengXianTao Maosheng Plastic Products Co., LtdFXO2023-03-31
10850044799593SURGYCOSurgyco LLCFXO2023-02-16
10850044799609SURGYCOSurgyco LLCFXO2023-02-16
10850044799616SURGYCOSurgyco LLCFXO2023-02-16
10850044799623SURGYCOSurgyco LLCFXO2023-02-16
10850044799630SURGYCOSurgyco LLCFXO2023-02-16
10850044799647SURGYCOSurgyco LLCFXO2023-02-16
10850044799654SURGYCOSurgyco LLCFXO2023-02-16
10850044799661SURGYCOSurgyco LLCFXO2023-02-16
10850044799678SURGYCOSurgyco LLCFXO2023-02-16
10850044799685SURGYCOSurgyco LLCFXO2023-02-16
00850044799596SURGYCOSurgyco LLCFXO2023-02-16
00850044799602SURGYCOSurgyco LLCFXO2023-02-16