AccessGUDID - DEVICE: HUDSON RCI (14026704743633)

GUDID

Device Identifier (DI) Information

Brand Name: HUDSON RCI
Version or Model: IPN924900
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2415-01
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704743633
Issuing Agency: GS1
Commercial Distribution End Date: October 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: Tracheostomy Adapter

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
35178	Tracheostomy mask, oxygen	A device designed to deliver oxygen or a mixture of oxygen and air to a patient who has a tracheostomy airway. It is connected to an oxygen/medical air source with tubing and is constructed of plastic. The device can be used over a tracheal tube or stoma. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZA	CONNECTOR, AIRWAY (EXTENSION)

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: Yes
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: b143c65d-34d1-4a29-9fb1-d33fadda5b09
Public Version Date: October 29, 2025
Public Version Number: 2
DI Record Publish Date: October 23, 2023