AccessGUDID - DEVICE: Air Time (00843356102703)

GUDID

Device Identifier (DI) Information

Brand Name: Air Time
Version or Model: HDF400Z
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CYGNUS MEDICAL L.L.C.

Primary DI Number: 00843356102703
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103169095 *Terms of Use

Device Description: AIRTIME™ HORIZONTAL DRYING, DIRECTIONAL FLOW TUBING SET. USED FOR DRYING COILED SCOPES. 4 TUBING PORTS

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):	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
JRJ	Unit, Drying

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: 36b6fea7-6ccc-4e4c-90ee-79456c1b9e98
Public Version Date: February 09, 2024
Public Version Number: 1
DI Record Publish Date: February 01, 2024