AccessGUDID - DEVICE: Nebu-Life (00853292007482)

GUDID

Device Identifier (DI) Information

Brand Name: Nebu-Life
Version or Model: RTG-07101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RTG-07101
Company Name: CUTTING EDGE HC BRANDS LLC

Primary DI Number: 00853292007482
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080216804 *Terms of Use

Device Description: Nebu-Life Hand Held Nebulizer 6cc Cup, w/7' Tube (2.1m). The Jet Nebulizer Bottle Set is used to administer various aerosal treatments to adults and pediatric patients in both the homecare and hospital settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

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:	Yes
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?
62680	Medicine chamber spacer, single-use	A non-sterile device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic, paper, or cardboard and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise be deposited in the mouth/upper airway, but are intended for the lower airway. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAF	Nebulizer (Direct Patient Interface)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091272	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
Device Size Text, specify: 6 cc Cup with 7 ft tube (2.1m)

Device Record Status

Public Device Record Key: 623605e4-341c-4f7b-8359-2bbcd81022c8
Public Version Date: May 11, 2020
Public Version Number: 2
DI Record Publish Date: February 25, 2019