AccessGUDID - DEVICE: NEBULIZER BOTTLE REUSABLE 6CC; OD:18mm,ONE PIECE (SET OF 5) (04716770324104)

GUDID

Device Identifier (DI) Information

Brand Name: NEBULIZER BOTTLE REUSABLE 6CC; OD:18mm,ONE PIECE (SET OF 5)
Version or Model: NB-32410
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BESMED HEALTH BUSINESS CORP.

Primary DI Number: 04716770324104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658023775 *Terms of Use

Device Description: NEBULIZER BOTTLE REUSABLE 6CC; OD:18mm,ONE PIECE (SET OF 5)

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?
10226	Atomizer, non-ventilatory	A non-powered, non-ventilatory device intended to provide liquid medication in an aerosolized airborne form for a patient to breathe. It is typically hand-operated. Unlike a nebulizer this devices lacks a baffle, therefore the particle size of the aerosol is not stabilized.	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
No Device Sizes

Device Record Status

Public Device Record Key: a27fd21d-41d8-4568-bddd-cb12081bc868
Public Version Date: June 08, 2021
Public Version Number: 4
DI Record Publish Date: December 14, 2017