AccessGUDID - DEVICE: AEROSIZER® (00884450031117)

GUDID

Device Identifier (DI) Information

Brand Name: AEROSIZER®
Version or Model: 00884450031117
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 90129-501/C
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 00884450031117
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184763290 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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):	No
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?
45679	Endoscopic measuring device, pulmonary stricture	A device used in conjunction with certain endoscopes (e.g., a rigid or flexible bronchoscope) to provide an atraumatic, direct measurement of the lumen and length of a pulmonary stricture for the indication of correct tracheobronchial stent selection. It is inserted through the working channel of the endoscope through which the physician views the site whilst operating this device to make the required measurements. It consists of a solid metal wire in a plastic sheath that terminates in expandable sizing arms at the distal end. The arms are operated by the physician through a syringe-like activation handle and a built-in indicator relates to the lumen diameter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDY	DEVICE, MEASURING, FOR PANENDOSCOPE

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: 4c385f40-3760-46e8-a943-b197c093aabf
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 04, 2016