AccessGUDID - DEVICE: HUDSON RCI (14026704648273)

GUDID

Device Identifier (DI) Information

Brand Name: HUDSON RCI
Version or Model: IPN049771
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1388
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704648273
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704594627

Device Description: Aerosol Face Tent with 6 ft. Corrugated Tubing

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?
12554	Aerosol tent, adult	A flexible enclosure designed for the top of a bed that is used to cover the head/torso of an adult patient to provide an aerosolized environment of breathing gases/vapours, e.g., a suspension of medicated liquid or solid particles, for medication therapy. It is typically used for the treatment of breathing disorders (e.g., asthma). It typically consists of a metal frame covered with transparent plastic, and wide bore tubing connected to the aerosol source. It is used to avoid direct attachment of the patient to a nasal cannula, face mask or endotracheal (ET) tube. This is a reusable 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: 40dc5737-29b1-4330-979f-1e626a5d36ef
Public Version Date: August 19, 2020
Public Version Number: 2
DI Record Publish Date: May 09, 2019