AccessGUDID - DEVICE: Custom Procedure Kit (40677964031555)

GUDID

Device Identifier (DI) Information

Brand Name: Custom Procedure Kit
Version or Model: 4005680
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4005680
Company Name: MEDIVATORS INC.

Primary DI Number: 40677964031555
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068199363 *Terms of Use

Device Description: Customs Procedure Kit includes Via basin, Enzymatic Sponge, Olympic DCSA Kit, Transport Pad, Lubricating Jelly, Gauze Pads, Suction Tubing, and Biohazard Sticker.

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: fff10ec2-0ad5-4f5d-b3b2-2d4d44906f77
Public Version Date: June 21, 2023
Public Version Number: 2
DI Record Publish Date: May 19, 2022