FDA.reportPublic FDA data

VIVIT

Primary DI
20810084210356
Brand
VIVIT
Company
1. Vivit International Inc
Model
970B
Device description
Overhead Film Gown, Thumbloops, Blue, Universal
Published
2021-10-30
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
FMEGown, Examination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810084210356PackageGS15In Commercial Distribution
10810084210359PrimaryGS10
00810084210352Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081008421035620810084210356
1081008421035910810084210359
00810084210352008100842103528100842103520810084210352

GMDN Terms#

Term, Definition table
TermDefinition
Professional examination gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. 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
815240958
Device count
15
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
10810084210007VIVIT8440FW2022-10-28
10810084210014VIVIT10112EM2021-10-30
10810084210021VIVIT8441FW2022-10-28
10810084210038VIVIT10111EM2021-10-30
10810084210045VIVIT30114EM2021-10-30
10810084210052VIVIT31314EM2021-10-30
10810084210069VIVIT313141EMV2021-10-30
10810084210076VIVIT10311TM2021-10-30
10810084210083VIVIT10215TM2021-10-30
10810084210090VIVIT30215TM2021-10-30
10810084210106VIVIT10333TM2021-10-30
10810084210113VIVIT11311TM2021-10-30
10810084210120VIVIT13313TM2021-10-30
10810084210137VIVIT12313TM2021-10-30
10810084210144VIVIT11215TM2021-10-30
10810084210151VIVIT30314TM2021-10-30
10810084210168VIVIT31314TM2021-10-30
10810084210175VIVIT313241TMV2021-10-30
10810084210182VIVIT313242TMV2021-10-30
10810084210199VIVIT205212021-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16975803530881GSOGroup Supply Organization Medical Technology(Shanghai) LtdFME2025-11-30
10097604573327Tronex International, Inc.TRONEX INTERNATIONAL, INC.FME2024-12-30
10850053289511SURGYCOSurgyco LLCFME2024-08-09
10850053289559SURGYCOSurgyco LLCFME2024-08-09
10850053289566SURGYCOSurgyco LLCFME2024-08-09
10850053289573SURGYCOSurgyco LLCFME2024-08-09
10850053289740SURGYCOSurgyco LLCFME2024-08-09
10850053289757SURGYCOSurgyco LLCFME2024-08-09
10810141931388VIVIT SupplyVivit Supply LLCFME2024-01-19
10810141931395VIVIT SupplyVivit Supply LLCFME2024-01-19
10850045738065UNCThe University of North Carolina Health SystemFME2023-10-31
10810141930473VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930480VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930497VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930503VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930176VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930183VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930190VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930206VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930213VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930220VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930237VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930244VIVIT SupplyVivit Supply LLCFME2023-09-10
10850044799890SURGYCOSurgyco LLCFME2023-06-30
10850044799906SURGYCOSurgyco LLCFME2023-06-30
10850044799913SURGYCOSurgyco LLCFME2023-06-30
10850044799937SURGYCOSurgyco LLCFME2023-06-30
10850044799944SURGYCOSurgyco LLCFME2023-06-30
20612899005482EncompassEncompass Group, L.L.C.FME2023-06-21
20612899005499EncompassEncompass Group, L.L.C.FME2023-06-21