AccessGUDID - DEVICE: Sidestream (00383730001517)

GUDID

Device Identifier (DI) Information

Brand Name: Sidestream
Version or Model: 00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4445A
Company Name: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Primary DI Number: 00383730001517
Issuing Agency: GS1
Commercial Distribution End Date: March 28, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 220018415 *Terms of Use

Device Description: Sidestream, Disposable, Case of 200.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
35457	Benchtop nebulizer, non-heated	An assembly of devices intended to be used in the home and clinical settings to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may be a benchtop or trolley-mounted assembly and includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K924123	000

Device Exempt from Premarket Submission: No 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: f2dffffa-f3aa-4444-bd46-1b920b37d45a
Public Version Date: March 29, 2023
Public Version Number: 5
DI Record Publish Date: August 24, 2016