FDA.reportPublic FDA data

Endo Carry-on Procedure Kit

Primary DI
00677964154089
Brand
Endo Carry-on Procedure Kit
Company
MEDIVATORS INC.
Model
4011449
Catalog number
4011449
Device description
Endo Carry-on Procedure Kit contains Basin, VIA Enzymatic Sponge, Dry Sponge, Defendo 4-piece kit, Drawstring Pad, Cleanascope Liners, Lubricant, Gauze, and Gown.
Published
2026-07-20
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

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
50677964154084PackageGS120In Commercial Distribution
00677964154089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5067796415408450677964154084
00677964154089006779641540896779641540890677964154089

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
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
00677964153877Endo Carry-on Procedure Kit401137340113732026-07-20
00677964153921Endo Carry-on Procedure Kit401139040113902026-07-20
00677964153976Endo Carry-on Procedure Kit401141240114122026-07-20
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
00677964153631Endo Carry-on Procedure Kit401123040112302026-05-26
00677964153648Endo Carry-on Procedure Kit401124340112432026-05-26
00677964153655Endo Carry-on Procedure Kit401124440112442026-05-26
00677964153662Endo Carry-on Procedure Kit401124540112452026-05-26
00677964153679Endo Carry-on Procedure Kit401121440112142026-05-26
00677964153686Endo Carry-on Procedure Kit401123640112362026-05-26
00677964153693Endo Carry-on Procedure Kit401123740112372026-05-26
00677964153709Endo Carry-on Procedure Kit401123840112382026-05-26
00677964153716Endo Carry-on Procedure Kit401125040112502026-05-26
00677964153723Endo Carry-on Procedure Kit401125240112522026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528358HALYARDAVID MEDICAL, INC.NWU2026-08-01
10198956441842CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956497740CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956501881CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956509511CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956519657CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956537132CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956539174CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956539891CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-31
10198956346567CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956373945CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
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10198956498402CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
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10198956519428CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956519855CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956520127CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956521179CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956523531CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956530942CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956531338CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956531765CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956532571CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956532649CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27
10198956534056CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-27