FDA.reportPublic FDA data

AERO®

Primary DI
00884450691007
Brand
AERO®
Company
Merit Medical Systems, Inc.
Model
00884450691007
Catalog number
90129-203/D
Published
2023-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JCTProsthesis, tracheal, expandable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCTProsthesis, Tracheal, ExpandableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450691007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450691007008844506910078844506910070884450691007

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450148174Merit Medical®Initial ReleaseK09-09012A2026-10-31
00884450428061Merit Medical®Initial ReleaseK10-01518B2026-10-31
00884450436936Merit Medical®Initial ReleaseK12-07972A2026-10-30
00884450499191Merit MAK™GMAK401N-E2026-10-30
00884450499221Merit MAK™GMAK401N2026-10-30
00884450499245Merit MAK™FMAK501N2026-10-30
00884450499870Merit S-MAK™FS-MAK501N2026-10-30
00884450500033Merit Medical®Initial ReleaseK09-05053T2026-10-30
00884450839362Prelude Roadster™APG8F45SX2026-10-30
00884450254677Merit Medical®Initial ReleaseK12-082752026-10-29
00884450838129Prelude Roadster™APG6F45MP2026-10-29
10884450708443Prelude®FPSI-7F-11-035-18G2026-10-29
00884450429150Merit Medical®Initial ReleaseK12-11133A2026-10-27
00884450436677Merit Medical®Initial ReleaseK09-10693C2026-10-27
00884450456286ReSolve®GRBDC-10-0382026-10-27
00884450838105Prelude Roadster™APG5F45S2026-10-03
00884450838143Prelude Roadster™APG6F45S2026-09-03
00884450838204Prelude Roadster™APG7F45S2026-09-02
00884450839119Prelude Roadster™APG5F45R2026-10-03
00884450839126Prelude Roadster™APG6F65MP2026-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450690765AERO DV®Merit Medical Systems, Inc.JCT2025-06-10
00884450690833AERO DV®Merit Medical Systems, Inc.JCT2024-05-22
00884450690758AERO DV®Merit Medical Systems, Inc.JCT2024-03-30
00884450703991AERO®Merit Medical Systems, Inc.JCT2024-03-27
00884450703960AERO®Merit Medical Systems, Inc.JCT2024-03-26
00884450690796AERO DV®Merit Medical Systems, Inc.JCT2024-03-22
00884450703984AERO®Merit Medical Systems, Inc.JCT2024-03-21
00884450704004AERO®Merit Medical Systems, Inc.JCT2024-03-19
00884450703939AERO®Merit Medical Systems, Inc.JCT2024-03-16
00884450704011AERO®Merit Medical Systems, Inc.JCT2024-03-16
00884450703922AERO®Merit Medical Systems, Inc.JCT2024-03-09
00884450703946AERO®Merit Medical Systems, Inc.JCT2024-03-08
00884450703977AERO®Merit Medical Systems, Inc.JCT2024-03-06
00884450690857AERO DV®Merit Medical Systems, Inc.JCT2024-01-03
00884450690734AERO DV®Merit Medical Systems, Inc.JCT2023-12-16
00884450690864AERO DV®Merit Medical Systems, Inc.JCT2023-12-13
00884450691403AERO DV®Merit Medical Systems, Inc.JCT2023-11-15
00884450690789AERO DV®Merit Medical Systems, Inc.JCT2023-11-10
00884450690840AERO DV®Merit Medical Systems, Inc.JCT2023-10-27
00884450691113AERO®Merit Medical Systems, Inc.JCT2023-10-13
00884450688823AEROmini®Merit Medical Systems, Inc.JCT2023-10-05
00884450690741AERO DV®Merit Medical Systems, Inc.JCT2023-10-05
00884450690819AERO DV®Merit Medical Systems, Inc.JCT2023-10-05
00884450625309AERO®Merit Medical Systems, Inc.JCT2023-09-28
00884450691069AERO®Merit Medical Systems, Inc.JCT2023-09-28
00884450710302AEROmini®Merit Medical Systems, Inc.JCT2023-09-20
00884450624944AERO®Merit Medical Systems, Inc.JCT2023-09-16
00884450688809AEROmini®Merit Medical Systems, Inc.JCT2023-09-16
00884450688885AEROmini®Merit Medical Systems, Inc.JCT2023-09-16
00884450688892AEROmini®Merit Medical Systems, Inc.JCT2023-09-16