FDA.reportPublic FDA data

Endo Carry-on Procedure Kit

Primary DI
00677964153495
Brand
Endo Carry-on Procedure Kit
Company
MEDIVATORS INC.
Model
4011189
Catalog number
4011189
Device description
Endo Carry-on Procedure Kit contains Intercept Bedside Kit, Defendo Olympus 5-piece Kit, Endo Carry-On Transport Pad, Lubricant, Gauze, Channel Cleaning Brush, and Valve Control Head Cleaning Brush.
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50677964153490PackageGS128In Commercial Distribution
00677964153495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5067796415349050677964153490
00677964153495006779641534956779641534950677964153495

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.

Contacts#

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

Regulatory Flags#

DUNS number
068199363
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995229641DEFENDO400805540080552024-03-25
00677964021695CER-1CER-178399-7232016-09-20
00677964033858DSD-201DSD-201 120VDSD20172016-09-20
00677964035647SSD-102SSD-102SSD20072016-09-20
00677964044755Advantage Plus Endoscope Reprocessing System1-2-510.0032016-09-16
00677964046674DSD Edge Endoscope Reprocessing SystemDSD Edge 120VDSD30082016-09-16
00677964052484CER-1 OptimaCER-1 OptimaCER1OPTIMA2016-09-20
00677964052491CER-2 OptimaCER-2 OptimaCER2OPTIMA2016-09-20
00677964095832Advantage Plus Pass-Thru1-2-610.003126100032018-02-06
00677964153877Endo Carry-on Procedure Kit401137340113732026-07-20
00677964153921Endo Carry-on Procedure Kit401139040113902026-07-20
00677964153976Endo Carry-on Procedure Kit401141240114122026-07-20
00677964154089Endo Carry-on Procedure Kit401144940114492026-07-20
00677964154096Endo Carry-on Procedure Kit401146040114602026-07-20
00677964051555Medivators HookupHookup58112CAS2024-04-01
00677964053450Medivators HookupHookup28338CAS2024-04-01
00677964002328Medivators HookupHookup28718CAS2023-04-10
00677964037856Medivators HookupHookup28612CAS2023-04-10
00677964153617Endo Carry-on Procedure Kit401122140112212026-05-26
00677964153624Endo Carry-on Procedure Kit401124240112422026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956553903CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956569331CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956595965CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956598355CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956602236CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605442CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605497CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956605640CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956607743CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956609723CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956609976CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10198956612648CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-19
10809160540756HALYARDAVID MEDICAL, INC.NWU2026-10-16
10198956565388CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-15
10198956596054CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-15
10198956602274CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-15
10198956589810CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-13
10198956598775CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-13
10198956391239CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956553408CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956556522CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956564701CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956574595CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956577077CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956584150CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956590793CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956590809CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956592742CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956598324CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12
10198956601826CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-12