AccessGUDID - DEVICE: Hudson RCI (04026704581290)

GUDID

Device Identifier (DI) Information

Brand Name: Hudson RCI
Version or Model: IPN040620
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 031-33J
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 04026704581290
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: NEBULIZER ADAPTOR 033,STERILE,JAPANESE

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Inhalation-therapy adaptor, reusable	A small connecting device, usually with a small channel, intended to join a sterile water pack or a sterile isotonic sodium chloride solution pack to an inhalation therapy device (e.g., humidifier, nebulizer, oxygen therapy delivery system) when the connection is not compatible (e.g., when the humidifier and the sterile water pack are of different manufacture). This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
CAF	NEBULIZER (DIRECT PATIENT INTERFACE)

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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 24030a01-8c0e-467d-bd55-1a5e4c562b20
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016