FDA.reportPublic FDA data

VIVIT Supply

Primary DI
20810141930548
Brand
VIVIT Supply
Company
Vivit Supply LLC
Model
851Y
Device description
AAMI 3 Isolation Gown, Neck Ties, Thumbloops with Elastic Cuff, Yellow, XL
Published
2023-09-15
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

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
20810141930548PackageGS110In Commercial Distribution
10810141930541PrimaryGS10
00810141930544Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081014193054820810141930548
1081014193054110810141930541
00810141930544008101419305448101419305440810141930544

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, and well ventilated space out of direct sunlight

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119042597
Device count
10
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
true
Expiration date on label
true
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
20810141933792VIVIT Supply201012026-02-26
20810141933808VIVIT Supply201022026-02-26
20810141933815VIVIT Supply201032026-02-26
20810141933822VIVIT Supply201042026-02-26
20810141933839VIVIT Supply201052026-02-26
20810141933877VIVIT Supply708812026-02-25
00810141933880VIVIT Supply708822026-02-25
20810141933891VIVIT Supply708832026-02-25
20810141933907VIVIT Supply708842026-02-25
20810141933914VIVIT Supply708852026-02-25
20810141933747VIVIT Supply205512026-02-03
20810141933754VIVIT Supply205522026-02-03
20810141933761VIVIT Supply205532026-02-03
20810141933778VIVIT Supply205542026-02-03
20810141933785VIVIT Supply205552026-02-03
20810141933488VIVIT Supply1112LJ2025-09-18
20810141933495VIVIT Supply1113LJ2025-09-18
20810141933501VIVIT Supply1114LJ2025-09-18
20810141933518VIVIT Supply1115LJ2025-09-18
20810141933525VIVIT Supply1116LJ2025-09-18

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