Merit MAK™

Primary DI
10884450144425
Brand
Merit MAK™
Company
Merit Medical Systems, Inc.
Model
00884450144428
Catalog number
MAK501NEBT/A
Published
2017-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031691000MERIT MAK (MINI ACCESS KIT)Merit Medical Systems, Inc.2003-09-03DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450144425PackageGS110In Commercial Distribution
00884450144428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445014442510884450144425
00884450144428008844501444288844501444280884450144428

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, single-useA sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
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
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
00884450486436Merit Medical®Initial ReleaseK09-144172026-07-09
00884450488812Merit Medical®Initial ReleaseK17-00021A2026-07-09
00884450437698Merit Medical®Initial ReleaseK09-09854C2026-07-08
00884450468913DuraMax®CH7871030280252026-07-08
00884450487273Merit Medical®Initial ReleaseK12T-02285H2026-07-08
00884450846254Flex-Neck®CCF-52602026-07-08
10884450415631Prelude®JPSI-6F-11-0252026-07-08
10884450415655Prelude®JPSI-6F-11-035-18G2026-07-08
10884450707781Prelude®FPSI-6F-11-0252026-07-08
10884450831554Tru-Cut®C2N2713X2026-07-08
00884450467039Merit Medical®Initial ReleaseK10T-03350D2026-07-07
00884450475812Merit Medical®Initial ReleaseK09-144032026-07-07
00884450486443Merit Medical®Initial ReleaseK09-143402026-07-07
00884450529348SplashWire™Initial ReleaseMSWSTFS381502026-07-07
00884450423790Merit Medical®Initial ReleaseK09-10667B2026-07-03
00884450438480Merit Medical®Initial ReleaseK10-03045C2026-07-03
00884450486337Merit Medical®Initial ReleaseK10T-062082026-07-03
00884450475805Merit Medical®Initial ReleaseK12T-05568F2026-06-27
00884450492864Merit Medical®Initial ReleaseK12T-05833B2026-06-27
00884450436202Merit Medical®Initial ReleaseK10-05785A2026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450415631Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450415655Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450707781Prelude®Merit Medical Systems, Inc.DRE2026-07-08
00884450860342Merit S-MAK™Merit Medical Systems, Inc.DRE2026-06-25
00884450468340Merit MAK™Merit Medical Systems, Inc.DRE2026-06-23
10884450706708Prelude®Merit Medical Systems, Inc.DRE2026-06-03
10884450415358Prelude®Merit Medical Systems, Inc.DRE2026-05-28
10841156105921VSITELEFLEX INCORPORATEDDRE2020-02-06
10841156105945VSITELEFLEX INCORPORATEDDRE2020-02-06
10841156105907VSITELEFLEX INCORPORATEDDRE2020-01-27
10841156105914VSITELEFLEX INCORPORATEDDRE2020-01-27
10841156105938VSITELEFLEX INCORPORATEDDRE2020-01-27
10841156105952VSITELEFLEX INCORPORATEDDRE2020-01-27
08714729295822NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
08714729295839NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
08714729295853NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
08714729375555NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
08714729742913NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
10827002237374EvolutionCook Vandergrift Inc.DRE2016-09-24
10827002237466EvolutionCook Vandergrift Inc.DRE2016-09-24
10827002237473EvolutionCook Vandergrift Inc.DRE2016-09-24
10827002465395EvolutionCook Vandergrift Inc.DRE2016-09-24
10827002465401EvolutionCook Vandergrift Inc.DRE2016-09-24
10827002465418EvolutionCook Vandergrift Inc.DRE2016-09-24
10884450007829Prelude®Merit Medical Systems, Inc.DRE2016-09-24
10884450007867Prelude®Merit Medical Systems, Inc.DRE2016-09-24
10884450007904Prelude®Merit Medical Systems, Inc.DRE2016-09-24
10884450008086Prelude®Merit Medical Systems, Inc.DRE2016-09-24
10884450008109Prelude®Merit Medical Systems, Inc.DRE2016-09-24
10884450008147Prelude®Merit Medical Systems, Inc.DRE2016-09-24