AccessGUDID - DEVICE: Endo Carry-on Custom Procedure Kit (40677964032125)

GUDID

Device Identifier (DI) Information

Brand Name: Endo Carry-on Custom Procedure Kit
Version or Model: 4005883
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4005883
Company Name: MEDIVATORS INC.

Primary DI Number: 40677964032125
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068199363 *Terms of Use

Device Description: Endo Carry-on Custom Procedure Kit includes Bedside Cleaning Tray, Enzymatic Sponge, 5-piece Olympus DCA Kit, Transport Pad, Lube Tube, Gauze Pads, Double Header Valve Brush, Slip Syringe and Biohazard Label.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61950	Endoscopy preparation kit	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWU	Endoscope introducer kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 32efa43d-62f0-47a7-b0f8-5cc5fd7014a2
Public Version Date: July 25, 2022
Public Version Number: 1
DI Record Publish Date: July 15, 2022