AccessGUDID - DEVICE: InnoSpire Essence (00383730001807)

GUDID

Device Identifier (DI) Information

Brand Name: InnoSpire Essence
Version or Model: 00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1095060
Company Name: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Primary DI Number: 00383730001807
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 220018415 *Terms of Use

Device Description: Innospire Essence Assembly, Plug A with120V 60HZ MOTOR

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

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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
Nebulizing system, non-heated	An assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.

GMDN Preferred Term Name

GMDN Definition

Nebulizing system, non-heated

An assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.

FDA Product Code

[?]

Product Code	Product Code Name
BTI	Compressor, air, portable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042655	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: 2c5d7fb8-2562-4364-8571-0090be4a2e6b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 24, 2016