FDA.reportPublic FDA data

VIVIT Supply

Primary DI
20810141930609
Brand
VIVIT Supply
Company
Vivit Supply LLC
Model
1120HW
Device description
Bouffant Cap, Spunbond, Small, 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

Product Codes#

Code, Name table
CodeName
FYFCap, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810141930609PackageGS15In Commercial Distribution
10810141930602PrimaryGS10
00810141930605Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081014193060920810141930609
1081014193060210810141930602
00810141930605008101419306058101419306050810141930605

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cap, single-useA head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. 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

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20810141933792VIVIT Supply201012026-02-26
20810141933808VIVIT Supply201022026-02-26
20810141933815VIVIT Supply201032026-02-26
20810141933822VIVIT Supply201042026-02-26
20810141933839VIVIT Supply201052026-02-26
20810141933877VIVIT Supply708812026-02-25
00810141933880VIVIT Supply708822026-02-25
20810141933891VIVIT Supply708832026-02-25
20810141933907VIVIT Supply708842026-02-25
20810141933914VIVIT Supply708852026-02-25
20810141933747VIVIT Supply205512026-02-03
20810141933754VIVIT Supply205522026-02-03
20810141933761VIVIT Supply205532026-02-03
20810141933778VIVIT Supply205542026-02-03
20810141933785VIVIT Supply205552026-02-03
20810141933488VIVIT Supply1112LJ2025-09-18
20810141933495VIVIT Supply1113LJ2025-09-18
20810141933501VIVIT Supply1114LJ2025-09-18
20810141933518VIVIT Supply1115LJ2025-09-18
20810141933525VIVIT Supply1116LJ2025-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344202212MEDLINEMEDLINE INDUSTRIES, INC.FYF2026-03-16
10810132043779HCSConcordance Healthcare Solutions LLCFYF2026-01-15
06979032640086GOBENHUZHOU JUNDA INDUSTRY CO., LTD.FYF2025-08-26
10813360021519ProtexerICP MEDICAL, LLCFYF2025-08-19
00810184641346GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641353GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641360GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641377GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641384GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184642442GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00850061859211GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00850061859877GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00850061859129GCB Medical Supply NovaplusGCB MEDICAL LLCFYF2025-07-23
00850061859143GCB Medical Supply NovaplusGCB MEDICAL LLCFYF2025-07-23
10827989003641Health Care Logistics, Inc®Health Care Logistics, Inc.FYF2025-04-22
TQ26126151700Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126151990Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126152000Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
20810141933235VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933242VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933259VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933266VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933273VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933280VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933297VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933303VIVIT SupplyVivit Supply LLCFYF2024-11-29
14719882252522CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06
14719882252546CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06
14719882252560CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06
14719882252584CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06