AccessGUDID - DEVICE: NebuTech® (00607411891854)

GUDID

Device Identifier (DI) Information

Brand Name: NebuTech®
Version or Model: 8987-7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8987-7
Company Name: SALTER LABS

Primary DI Number: 00607411891854
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022721133 *Terms of Use

Device Description: NebuTech® HDN® Nebulizer with inhalation valve and Adult I-Guard™ valved mask-aerosol delivery system (vinyl). 7’ (84”) tubing

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	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 [?]
K961476	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: b2b9ba25-7644-4d10-a0ec-f7d71d577550
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016