FDA.reportPublic FDA data

VIA

Primary DI
10816765015930
Brand
VIA
Company
US Endoscopy
Model
00717219
Catalog number
00717219
Device description
The VIA procedure kit custom includes transport pad, gauze pads, biohazard sticker, Via basin, enzymatic sponge, lubricating jelly, suction tubing, DuoSwift squeegee brush, BioGuard 4 piece kit, and BioGuard AW cleaning adapter.
Published
2019-08-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816765015930PackageGS118Not in Commercial Distribution
00816765015933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081676501593010816765015930
00816765015933008167650159338167650159330816765015933

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopy preparation kitA collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); it does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995233327Duoswift00711600007116002026-03-12
10724995362635VIAVIA Custom Procedure Kit007174412026-03-06
10724995362642VIAVIA Custom Procedure Kit007174422026-03-06
10724995362659VIAVIA Custom Procedure Kit007174432026-03-06
10724995243750Exacto Mundo00711078007110782025-08-19
10724995243767Exacto Mundo00711079007110792025-08-19
10724995244535Lumiflex00733223007332232025-08-19
00724995244545Lumiflex00715506W00715506W2025-06-03
00724995244552Lumiflex00715508W00715508W2025-06-03
00724995244569Lumiflex00715510W00715510W2025-06-03
00724995244576Lumiflex00715512W00715512W2025-06-03
00724995244583Lumiflex00715515W00715515W2025-06-03
00724995244590Lumiflex00715518W00715518W2025-06-03
00724995244606Lumiflex00715506007155062025-06-03
00724995244613Lumiflex00715508007155082025-06-03
00724995244620Lumiflex00715510007155102025-06-03
00724995244637Lumiflex00715512007155122025-06-03
00724995244644Lumiflex00715515007155152025-06-03
00724995244651Lumiflex00715518007155182025-06-03
00724995244668Lumiflex00718006W00718006W2025-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00677964153617Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153624Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153631Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153648Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153655Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153662Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153679Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153686Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153693Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153709Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153716Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153723Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153730Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153747Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153754Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153761Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153778Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
00677964153785Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-05-26
10198956057005CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956358003CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956376953CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956441071CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956444508CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956454460CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956463042CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956463264CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956465183CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956469297CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956480889CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25
10198956484313CARDINAL HEALTHCardinal Health 200, LLCNWU2026-05-25