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AEROmini®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
AEROmini® FDA UDI
Generic Name
Polymeric tracheal/bronchial stent, non-bioabsorbable FDA UDI
Model / Reference
00884450688786 FDA UDI

Identifiers

Catalog Number
AERO1215/D FDA UDI
Primary DI / UDI-DI
00884450688786 FDA UDI
FDA Product Code
JCT FDA UDI
GMDN Term
Polymeric tracheal/bronchial stent, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3720 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Polymeric tracheal/bronchial stent, non-bioabsorbable

The AEROmini device is a non-bioabsorbable, polymeric tracheal/bronchial stent designed to maintain luminal patency in patients with certain medical conditions. It is intended for implantation into the trachea and/or bronchus/bronchiole, using various designs to conform to the endotracheal/endobronchial surface.

Similar devices

Also classified as Polymeric tracheal/bronchial stent, non-bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI a942ad68-ef3f-463c-b658-4ff9b80b06df 34 fields · synced Jul 14, 2026