Device
Endo Carry-on Procedure Kit contains Basin, VIA Enzymatic Sponge, Defendo Fuji 700 4-piece Kit, Transport Pad, Lubricant, Gauze, Suction Tubing, Gowns, and Biohazard Sticker.
Manufacturer
MEDIVATORS INC.
MEDIVATORS INC.
Model: 4011194
Catalog: 4011194
DI: 00677964153549
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
Endo Carry-on Procedure Kit contains Basin, VIA Enzymatic Sponge, Defendo Fuji 700 4-piece Kit, Transport Pad, Lubricant, Gauze, Suction Tubing, Gowns, and Biohazard Sticker.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b079273e-0877-42d7-9d8d-01c3464023b0
Distribution Status:
In Commercial Distribution
DUNS Number:
068199363
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
50677964153544
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
12
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00677964153549
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00677964153549
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 61950
Name: Endoscopy preparation kit
Definition:
A 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.
FDA Product Codes
NWU
Endoscope introducer kit