AccessGUDID - DEVICE: HUDSON RCI (14026704648037)

GUDID

Device Identifier (DI) Information

Brand Name: HUDSON RCI
Version or Model: IPN913886
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1041
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704648037
Issuing Agency: GS1
Commercial Distribution End Date: October 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704387540

Device Description: ADULT Medium Concentration Elongated SEE-THRU® Oxygen Mask

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:	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?
35171	Rebreathing oxygen face mask	A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYG	MASK, OXYGEN

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: d6994ad4-22f9-4f61-8e1b-6593d7df2f21
Public Version Date: October 29, 2025
Public Version Number: 2
DI Record Publish Date: August 21, 2020