AEROmini® AERO1215

GUDID 10884450362768

Merit Medical Systems, Inc.

Polymeric tracheal/bronchial stent, non-bioabsorbable, sterile

Primary Device ID	10884450362768
NIH Device Record Key	78be7844-52d6-44e1-a425-1a5c1289b73d
Commercial Distribution Status	In Commercial Distribution
Brand Name	AEROmini®
Version Model Number	00884450362761
Catalog Number	AERO1215
Company DUNS	184763290
Company Name	Merit Medical Systems, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450362761 [Primary]
GS1	10884450362768 [Package] Contains: 00884450362761 Package: [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K140382

FDA Product Code

JCT	Prosthesis, tracheal, expandable

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-07-12
Device Publish Date	2018-06-11

On-Brand Devices [AEROmini®]

10884450362768	00884450362761
10884450230999	00884450230992
10884450230982	00884450230985
10884450230968	00884450230961
10884450229917	00884450229910
10884450229856	00884450229859
10884450229849	00884450229842
10884450229832	00884450229835
10884450229825	00884450229828
10884450307950	00884450307953
10884450307936	00884450307939
10884450307929	00884450307922
10884450307912	00884450307915
10884450307875	00884450307878
00884450688786	00884450688786
00884450688878	00884450688878
00884450688892	00884450688892
00884450688885	00884450688885
00884450688809	00884450688809
00884450710302	00884450710302
00884450688823	00884450688823

Trademark Results [AEROmini]

Mark Image Registration \| Serial	Company Trademark Application Date
AEROMINI 86057056 4777850 Live/Registered	Merit Medical Systems, Inc. 2013-09-05