AccessGUDID - DEVICE: Roscoe Medical (00092237603161)

GUDID

Device Identifier (DI) Information

Brand Name: Roscoe Medical
Version or Model: NEB-ROS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: COMPASS HEALTH BRANDS CORP.

Primary DI Number: 00092237603161
Issuing Agency: GS1
Commercial Distribution End Date: May 07, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 827221698 *Terms of Use

Device Description: Roscoe Mini Neb Compressor and

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?
66295	Ambulatory nebulizer, non-heated	An electrically-powered, hand-held, portable device intended to be used in the home to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may employ various technologies (ultrasonic, vibrating mesh, or compressor jet type) and consists of a pocket-size unit containing a reservoir to be filled with medication/fluids, and a retractable mouthpiece or attached mask. This device is not a nebulizing chamber.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 9b19cf54-f66a-423f-89e2-ab6c8a43b5ae
Public Version Date: August 24, 2023
Public Version Number: 4
DI Record Publish Date: October 04, 2016