AccessGUDID - DEVICE: LMA ATOMIZATION (14026704613134)

GUDID

Device Identifier (DI) Information

Brand Name: LMA ATOMIZATION
Version or Model: IPN048829
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MAD140
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704613134
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 14026704709844

Device Description: MAD Nasal with 3 mL Syringe & Adapter

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

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 6a51fb3e-1f5b-4a1b-8fc0-6e3933add590
Public Version Date: March 08, 2024
Public Version Number: 5
DI Record Publish Date: September 13, 2017