FDA.reportPublic FDA data

VIVIT Supply

Primary DI
10810141932545
Brand
VIVIT Supply
Company
Vivit Supply LLC
Model
548DL
Device description
Phoenix Double Layer Two-Color Sterilization Wrap, V500, 48in x 48in, 122cm x 122cm, Purple + Blue
Published
2024-10-04
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
FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEGTube, Double Lumen For Intestinal Decompression And/Or IntubationGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810141932542PackageGS12In Commercial Distribution
10810141932545PrimaryGS10
00810141932548Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081014193254220810141932542
1081014193254510810141932545
00810141932548008101419325488101419325480810141932548

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
DM exempt
false
Premarket exempt
false
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
10810141930008VIVIT Supply10112EM2023-09-15
10810141930015VIVIT Supply10111EM2023-09-15
10810141930022VIVIT Supply30114EM2023-09-15
10810141930039VIVIT Supply31314EM2023-09-15
10810141930046VIVIT Supply313141EMV2023-09-15
10810141930053VIVIT Supply10311TM2023-09-15
10810141930060VIVIT Supply10215TM2023-09-15
10810141930084VIVIT Supply10333TM2023-09-15
10810141930091VIVIT Supply11311TM2023-09-15
10810141930107VIVIT Supply13313TM2023-09-15
10810141930121VIVIT Supply11215TM2023-09-15
10810141930138VIVIT Supply30314TM2023-09-15
10810141930145VIVIT Supply31314TM2023-09-15
10810141930152VIVIT Supply313241TMV2023-09-15
10810141930169VIVIT Supply313242TMV2023-09-15
10810141930176VIVIT Supply130Y2023-09-10
10810141930183VIVIT Supply131Y2023-09-10
10810141930190VIVIT Supply230Y2023-09-10
10810141930206VIVIT Supply231Y2023-09-10
10810141930336VIVIT Supply205212023-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253012460Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253012484Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253012507Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253012521Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253012989Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253013009Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253060928Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253012468Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253012482Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253012529Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253013007Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253060926Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253006872Salem SumpCardinal Health 200, LLCFEG2026-01-16
10192253006889Salem SumpCardinal Health 200, LLCFEG2026-01-16
10192253006902Salem SumpCardinal Health 200, LLCFEG2026-01-16
10192253012767Salem SumpCardinal Health 200, LLCFEG2026-01-16
50192253006870Salem SumpCardinal Health 200, LLCFEG2026-01-16
50192253006887Salem SumpCardinal Health 200, LLCFEG2026-01-16
50192253006900Salem SumpCardinal Health 200, LLCFEG2026-01-16
50192253012765Salem SumpCardinal Health 200, LLCFEG2026-01-16
20810141932542VIVIT SupplyVivit Supply LLCFEG2024-10-04
10884521740693Salem SumpCardinal Health, Inc.FEG2024-03-11
10884521740709Salem SumpCardinal Health, Inc.FEG2024-03-11
10884521740716Salem SumpCardinal Health, Inc.FEG2024-03-11
10884521740723Salem SumpCardinal Health, Inc.FEG2024-03-11
10884521740730Salem SumpCardinal Health, Inc.FEG2024-03-11
20884521740690Salem SumpCardinal Health, Inc.FEG2024-03-11
20884521740720Salem SumpCardinal Health, Inc.FEG2024-03-11
10884389965757MedlineMEDLINE INDUSTRIES, INC.FEG2024-02-16
40884389965758MedlineMEDLINE INDUSTRIES, INC.FEG2024-02-16