FDA.reportPublic FDA data

Merit MAK™

Primary DI
00884450499221
Brand
Merit MAK™
Company
Merit Medical Systems, Inc.
Model
G
Catalog number
MAK401N
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450499228PackageGS110In Commercial Distribution
00884450499221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445049922810884450499228
00884450499221008844504992218844504992210884450499221

Device Sizes#

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

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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
00884450839133Prelude Roadster™APG6F65S2026-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450499191Merit MAK™Merit Medical Systems, Inc.DRE2026-10-30
00884450499245Merit MAK™Merit Medical Systems, Inc.DRE2026-10-30
00884450499870Merit S-MAK™Merit Medical Systems, Inc.DRE2026-10-30
00884450839362Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-30
00884450838129Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-29
10884450708443Prelude®Merit Medical Systems, Inc.DRE2026-10-29
00884450840610Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-20
00884450838105Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-03
00884450839119Prelude Roadster™Merit Medical Systems, Inc.DRE2026-10-03
00884450838143Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-03
00884450839126Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-03
00884450838204Prelude Roadster™Merit Medical Systems, Inc.DRE2026-09-02
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-27
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-18
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DRE2026-07-31
00884450839133Prelude Roadster™Merit Medical Systems, Inc.DRE2026-06-19
00884450839140Prelude Roadster™Merit Medical Systems, Inc.DRE2026-05-09
00884450838365Abiomed®Merit Medical Systems, Inc.DRE2025-07-01
00884450770764Prelude Roadster™Merit Medical Systems, Inc.DRE2023-12-13
00884450770771Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-28
00884450770788Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-11
00884450770757Prelude Roadster™Merit Medical Systems, Inc.DRE2023-10-05
00884450732311Abiomed®Merit Medical Systems, Inc.DRE2023-06-30
00884450532577Prelude Roadster™Merit Medical Systems, Inc.DRE2022-12-28
00884450532522Prelude Roadster™Merit Medical Systems, Inc.DRE2022-12-15
00884450531952Prelude Roadster™Merit Medical Systems, Inc.DRE2022-11-12
00884450532348Prelude Roadster™Merit Medical Systems, Inc.DRE2022-11-01
00884450532171Prelude Roadster™Merit Medical Systems, Inc.DRE2022-10-28
00884450531914Prelude Roadster™Merit Medical Systems, Inc.DRE2022-10-19
00884450532607Prelude Roadster™Merit Medical Systems, Inc.DRE2022-10-01