FDA.reportPublic FDA data

VIVIT Supply

Primary DI
10810141931036
Brand
VIVIT Supply
Company
Vivit Supply LLC
Model
22FS
Device description
Face Shield, 3/4 Length, Anti-Glare / Anti-Fog Shield
Published
2023-09-15
Public version status
Update
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
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810141931033PackageGS19In Commercial Distribution
10810141931036PrimaryGS10
00810141931039Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081014193103320810141931033
1081014193103610810141931036
00810141931039008101419310398101419310390810141931039

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shield, single-useA clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.

Storage And Handling#

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

Regulatory Flags#

DUNS number
119042597
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
10810141930695VIVIT Supply206252023-09-16
10810141930701VIVIT Supply206242023-09-16
10810141930718VIVIT Supply206232023-09-16
10810141930725VIVIT Supply206222023-09-16
10810141930732VIVIT Supply206212023-09-16
10810141930893VIVIT Supply10116PM2023-09-15
10810141931012VIVIT Supply11111EM2023-12-15
10810141931500VIVIT Supply359112024-05-17
10810141931753VIVIT Supply206262024-04-26
10810141932910VIVIT Supply372SL2024-10-04
10810141933399VIVIT Supply/Caracal201452025-08-07
10810141933740VIVIT Supply205512026-02-03
10810141933757VIVIT Supply205522026-02-03
10810141933764VIVIT Supply205532026-02-03
10810141933771VIVIT Supply205542026-02-03
10810141933788VIVIT Supply205552026-02-03
10810141930008VIVIT Supply10112EM2023-09-15
10810141930015VIVIT Supply10111EM2023-09-15
10810141930022VIVIT Supply30114EM2023-09-15
10810141930039VIVIT Supply31314EM2023-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456218402JMUJMU DENTAL, INCLYU2026-07-06
00840456218419JMUJMU DENTAL, INCLYU2026-07-06
00840456218426JMUJMU DENTAL, INCLYU2026-07-06
00840456218433JMUJMU DENTAL, INCLYU2026-07-06
00840456218440JMUJMU DENTAL, INCLYU2026-07-06
00840456218457JMUJMU DENTAL, INCLYU2026-07-06
00840456218464JMUJMU DENTAL, INCLYU2026-07-06
00840456218471JMUJMU DENTAL, INCLYU2026-07-06
00840456218488JMUJMU DENTAL, INCLYU2026-07-06
00840456218495JMUJMU DENTAL, INCLYU2026-07-06
00840456220894JMUJMU DENTAL, INCLYU2026-07-06
00840456220900JMUJMU DENTAL, INCLYU2026-07-06
00840456220917JMUJMU DENTAL, INCLYU2026-07-06
00840456220924JMUJMU DENTAL, INCLYU2026-07-06
00840456220931JMUJMU DENTAL, INCLYU2026-07-06
00840456220948JMUJMU DENTAL, INCLYU2026-07-06
00840456220955JMUJMU DENTAL, INCLYU2026-07-06
00840456220962JMUJMU DENTAL, INCLYU2026-07-06
00840456220979JMUJMU DENTAL, INCLYU2026-07-06
00840456220986JMUJMU DENTAL, INCLYU2026-07-06
00840456224328JMUJMU DENTAL, INCLYU2026-07-06
G3731331500Zinnanti SurgicalZinnanti Surgical Design Group IncLYU2026-06-10
00810219420014American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420038American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420052American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420069American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420076American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420083American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00850073571996American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420090American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09