FDA.report

VIA

Primary DI
00816765014172
Brand
VIA
Company
US Endoscopy
Model
00717044
Catalog number
00717044
Device description
The VIA Procedure Kit - custom includes transport pad, gauze pads, basin, Via enzymatic sponge, lubricating jelly, and BioGuard air/water and suction valves.
Published
2020-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NWUEndoscope introducer kit

Product Code Classifications

CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10724995181366PackageGS118In Commercial Distribution
00816765014172PreviousGS10
00724995181369PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
1072499518136614107249951813661Indicator 1 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
00816765014172140081676501417208167650141720816765014172Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.
00724995181369140072499518136907249951813690724995181369Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

GMDN Terms

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

Contacts

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

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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

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