AccessGUDID - DEVICE: Dri-Scope Aid - Jet-Stream - Air Filter (0.1µm) Kit (1 pack) (00810053600917)

GUDID

Device Identifier (DI) Information

Brand Name: Dri-Scope Aid - Jet-Stream - Air Filter (0.1µm) Kit (1 pack)
Version or Model: 402119-210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 402119-210
Company Name: TRICOR SYSTEMS, INC.

Primary DI Number: 00810053600917
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070164694 *Terms of Use

Device Description: Dri-Scope Aid Jet-Stream; 6-month HEPA Filter Kit; 0.1 µm; 1 pack; The Dri-Scope Aid Jet-Stream 6-month replacement filter (qty 1). Consult TRICOR Systems Inc to determine what Dri-Scope Aid Jet-Stream maintenance items are required to support your system and maintain compliance.

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):	No
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?
65046	Endoscope dryer	An electrically-powered assembly of devices designed to dry the internal channel of an endoscope after washing, and to maintain dryness during storage, to prevent bacterial growth and endoscope deterioration. It consists of a user interface, a control unit, tubing/connectors for attaching to the endoscope, and may incorporate either an internal air pump or a connection for standard medical air supply; it may be designed for use on a bench or in a cabinet.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNL	Accessories, Cleaning Brushes, For Endoscope

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: 1cc9d673-c487-4974-a936-5387210d1ac0
Public Version Date: March 24, 2025
Public Version Number: 1
DI Record Publish Date: March 14, 2025