AccessGUDID - DEVICE: HUDSON RCI (14026704648259)

GUDID

Device Identifier (DI) Information

Brand Name: HUDSON RCI
Version or Model: IPN913903
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1098
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704648259
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704594405

Device Description: ADULT SELECT-A-VENT™ Air Entrainment Mask Kit with Fixed Diluter

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?
35175	Venturi oxygen face mask	A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. The device typically includes a variety of exchangeable inserts (the venturi) that allow air entrainment in controlled amounts to provide the desired O2 concentration. It is connected to an O2 source with tubing and includes headstraps for stabilization. Adaptors are typically included for connection to a humidification source. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYF	MASK, OXYGEN, LOW CONCENTRATION, VENTURI

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: 2260e9c5-e5de-4394-ad1f-e4d56f55e175
Public Version Date: August 19, 2020
Public Version Number: 2
DI Record Publish Date: May 09, 2019