FDA.reportPublic FDA data

AEROSIZER®

Primary DI
00884450031117
Brand
AEROSIZER®
Company
Merit Medical Systems, Inc.
Model
00884450031117
Catalog number
90129-501/C
Published
2016-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Single use
true

Product Codes#

Code, Name table
CodeName
FDYDEVICE, MEASURING, FOR PANENDOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDYDevice, Measuring, For PanendoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450031117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450031117008844500311178844500311170884450031117

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
Premarket exempt
true
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
00884450833919AEROSIZER®Merit Medical Systems, Inc.FDY2025-05-12