FDA.reportPublic FDA data

AERO DV®

Primary DI
10884450030940
Brand
AERO DV®
Company
Merit Medical Systems, Inc.
Model
00884450030943
Catalog number
90129-305/C
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083625000AERO DV TRACHEOBRONCHIAL STENT SYSTEMAlveolus, Inc.2009-03-11JCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450030940PackageGS11In Commercial Distribution
00884450030943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445003094010884450030940
00884450030943008844500309438844500309430884450030943

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00884450691007AERO®Merit Medical Systems, Inc.JCT2023-09-26
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