FDA.reportPublic FDA data

AERO DV®

Primary DI
00884450030998
Brand
AERO DV®
Company
Merit Medical Systems, Inc.
Model
00884450030998
Catalog number
90129-316/C
Published
2016-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
10884450030995PackageGS11In Commercial Distribution
00884450030998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445003099510884450030995
00884450030998008844500309988844500309980884450030998

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric tracheal/bronchial stent, non-bioabsorbableA non-bioabsorbable tubular device intended to be implanted into the trachea and/or a bronchus/bronchiole to maintain luminal patency, typically used in cases of obstructions/stenoses, fistulae, tumours, scarring, surgical resection and anastomosis, or pulmonary transplantation. It is made entirely of a synthetic polymer(s) [e.g., silicone] and may have various designs (e.g., semi-soft continuous tube, covered or non-covered mesh structure, straight or branched configuration) intended to conform to the endotracheal/endobronchial surface. It may be expandable in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.

Device Sizes#

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

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
00884450376713Merit Medical®Initial ReleaseK09-08747L2026-10-06
00884450428344Merit Medical®Initial ReleaseK11-01422A2026-10-06
10884450438791Prelude® Short SheathBPSS-8F-4-018MT2026-10-06
00884450029756Merit Medical®Initial ReleaseK08-02280A2026-09-29
00884450421383Merit Medical®Initial ReleaseK09-09424A2026-09-29
00884450431917Merit Medical®Initial ReleaseK09-13874B2026-09-29
00884450436004Merit Medical®Initial ReleaseK12-05438A2026-09-29
00884450452974MAK-NV™DMAK-NV-0082026-09-29
00884450453339MAK-NV™DMAK-NV-0162026-09-29
00884450500002Merit Medical®Initial ReleaseK09-144152026-09-29
10884450119751Prelude EASE™JPHR6F11018SC2026-09-29
10884450280055Prelude®JPSI-4F-11-0182026-09-29
10884450415839Prelude®JPSI-7F-11-0182026-09-29
10884450439163Prelude IDeal™JPID6F11021SSC2026-09-29
10884450439187Prelude IDeal™JPID6F11021PW2026-09-29
10884450452353STAR™FRF-0510L-012026-09-29
10884450831547Tru-Cut®C2N2712X2026-09-29
00884450376867Merit Medical®Initial ReleaseK09-10502F2026-09-26
00884450431597Merit Medical®Initial ReleaseK09-12862A2026-09-26
00884450432105Merit Medical®Initial ReleaseK09-08926B2026-09-26

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