AccessGUDID - DEVICE: N/A (00607411890406)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 8936-7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8936-7
Company Name: SALTER LABS

Primary DI Number: 00607411890406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022721133 *Terms of Use

Device Description: Nebulizer (Pediatric) with aerosol mask, 7’ (2.1 m) supply tube, elastic strap fixation.

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:	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
CCQ	NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K870027	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
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Adult

Device Record Status

Public Device Record Key: 0ddc494d-6d6d-49f8-81c1-98e36962ee50
Public Version Date: September 24, 2025
Public Version Number: 5
DI Record Publish Date: September 24, 2016