FDA.reportPublic FDA data

VIVIT Supply

Primary DI
20810141933334
Brand
VIVIT Supply
Company
Vivit Supply LLC
Model
436B
Device description
Overhead AAMI 4 Open Back Gown, Knit Cuff, Blue, Universal
Published
2025-06-18
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
FYAGown, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810141933334PackageGS110In Commercial Distribution
10810141933337PrimaryGS10
00810141933330Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081014193333420810141933334
1081014193333710810141933337
00810141933330008101419333308101419333300810141933330

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.

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
10810141931401VIVIT Supply201212024-03-26
10810141931418VIVIT Supply201222024-03-26
10810141931425VIVIT Supply201232024-03-26
10810141931432VIVIT Supply201242024-03-26
10810141931449Vivit Supply201252024-03-26
10810141933924VIVIT Supply10218EM2026-05-08
10810141933832VIVIT Supply201052026-02-26
10810141933795VIVIT Supply201012026-02-26
10810141933801VIVIT Supply201022026-02-26
10810141933818VIVIT Supply201032026-02-26
10810141933825VIVIT Supply201042026-02-26
20810141933792VIVIT Supply201012026-02-26
20810141933808VIVIT Supply201022026-02-26
20810141933815VIVIT Supply201032026-02-26
20810141933822VIVIT Supply201042026-02-26
20810141933839VIVIT Supply201052026-02-26
10810141933870VIVIT Supply708812026-02-25
10810141933887VIVIT Supply708822026-02-25
10810141933894VIVIT Supply708832026-02-25
10810141933900VIVIT Supply708842026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518442430SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442447SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442454SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442461SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
09009607822207ViVi TOGA Premium Size XL-XXLTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607822214ViVi TOGA Premium Size M-LTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607822221ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832206ViVi TOGA Premium Size XL-XXLTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832213ViVi TOGA Premium Size M-LTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832220ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
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