FDA.report

Vivit Suppy

Primary DI
20810141930630
Brand
Vivit Suppy
Company
Vivit Supply LLC
Model
8431FW
Device description
Shoe Cover, Spunbond, XL, Blue
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

Related Records

Product Codes

CodeName
FXPCover, Shoe, Operating-Room

Product Code Classifications

CodeDeviceSpecialtyClass
FXPCover, Shoe, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20810141930630PackageGS15In Commercial Distribution
10810141930633PrimaryGS10
00810141930636Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2081014193063020810141930630
1081014193063310810141930633
00810141930636008101419306368101419306360810141930636

GMDN Terms

TermDefinition
Shoe coverA loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.

Storage And Handling

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

Sterilization Methods

Method

Regulatory Flags

DUNS number
119042597
Device count
250
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

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10810132044349HCSConcordance Healthcare Solutions LLCFXP2026-03-09
10197344133123MEDLINEMEDLINE INDUSTRIES, INC.FXP2026-03-06
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00612479250574McKessonMCKESSON MEDICAL-SURGICAL INC.FXP2025-03-18
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