AccessGUDID - DEVICE: InnoSpire Elegance (00383730002880)

GUDID

Device Identifier (DI) Information

Brand Name: InnoSpire Elegance
Version or Model: 00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1104143
Company Name: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Primary DI Number: 00383730002880
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 220018415 *Terms of Use

Device Description: Innospire Elegance, Custom wDVD St. Bag, 6 pack.

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?
35457	Therapeutic agent nebulizer, benchtop	An assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It 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. It is designed to be placed on a benchtop/flat surface during use.	Active	false

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: c0e24b6f-ea16-4929-97ff-b63e2968b9b7
Public Version Date: September 24, 2025
Public Version Number: 5
DI Record Publish Date: August 24, 2016