FDA.reportPublic FDA data

VIVIT Supply

Primary DI
10810141932422
Brand
VIVIT Supply
Company
Vivit Supply LLC
Model
348DL
Device description
Sterilization Wrap, Fused Two Color, Purple & Blue, V300, 48 X 48
Published
2024-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810141932429PackageGS14In Commercial Distribution
10810141932422PrimaryGS10
00810141932425Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081014193242920810141932429
1081014193242210810141932422
00810141932425008101419324258101419324250810141932425

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. 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
24
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20680651497677HalyardO&M HALYARD, INC.FRG2026-07-16
20680651497684HalyardO&M HALYARD, INC.FRG2026-07-16
00859464007731Turbett Surgical, Inc.Turbett Surgical IncFRG2026-07-14
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08404535030761Brasseler USAPeter Brasseler Holdings, LLCFRG2026-07-13
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