FDA.reportPublic FDA data

VIVIT Supply

Primary DI
20810141931392
Brand
VIVIT Supply
Company
Vivit Supply LLC
Model
981B
Device description
Overhead Film Gown, Thumbloops, Blue, XL
Published
2024-01-19
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
20810141931392PackageGS16In Commercial Distribution
10810141931395PrimaryGS10
00810141931398Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081014193139220810141931392
1081014193139510810141931395
00810141931398008101419313988101419313980810141931398

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
119042597
Device count
20
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
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
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