AccessGUDID - DEVICE: Silicone connection set for ultrasound endoscopes PENTAX 70K and J10 series (03701354402508)

GUDID

Device Identifier (DI) Information

Brand Name: Silicone connection set for ultrasound endoscopes PENTAX 70K and J10 series
Version or Model: PW Enew
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PLASMABIOTICS

Primary DI Number: 03701354402508
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 262972663 *Terms of Use

Device Description: Silicone connection set for ultrasound endoscopes PENTAX 70K and J10 series

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
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?
61445	Endoscope clean-storage system	A mobile, mains electricity (AC-powered) assembly of devices intended to prepare, bag, label and register disinfected and sterilized endoscopes prior to long-term storage. It typically includes: 1) a fluid preparation assembly such as fluid pump, tubing and a preparation solution (e.g., hydrogen peroxide solution); 2) devices intended to achieve sealed-storage such as trays, sterile liners, vacuum bags, and a vacuum pump; 3) labelling/registration devices (i.e., bar-code printer and bar-code reader); and 4) a computer with integrated software for process/data management. It is not intended to clean, disinfect or sterilize but to maintain the sterilized/disinfected state of the endoscope.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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
Length: 34 Centimeter
Width: 23 Centimeter
Height: 3 Centimeter

Device Record Status

Public Device Record Key: d88647d4-0489-4b73-ae46-8230f139eec1
Public Version Date: May 21, 2021
Public Version Number: 1
DI Record Publish Date: May 13, 2021