AccessGUDID - DEVICE: I-neb In Vitro Test Disc Power 10 (00383730004587)

GUDID

Device Identifier (DI) Information

Brand Name: I-neb In Vitro Test Disc Power 10
Version or Model: 1003419
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1003419
Company Name: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Primary DI Number: 00383730004587
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 220018415 *Terms of Use

Device Description: I-neb In Vitro Test Disc Power 10

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):	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?
12719	Ultrasonic nebulizing system	An assembly of devices designed to generate aerosolized medication/fluids (finely dispersed airborne droplets) for inhalation by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It typically consists of a mains electricity (AC-powered) electronic oscillator, an ultrasound transducer (piezoelectric crystal), a coupling basin, a nebulizer chamber and a fan. A high frequency (e.g., 1-2 MHz) electrical current is applied to the crystal within the oscillator circuit converting it to vibrations which produce sound waves. The coupler (water or saline) transmits the sound waves to the medicated solution in the nebulizing chamber.	Obsolete	false

FDA Product Code

[?]

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: 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: e4c3ebe2-f76b-444b-b2f2-9d990b3cf48a
Public Version Date: April 01, 2020
Public Version Number: 1
DI Record Publish Date: March 24, 2020