Merit PAK™

Primary DI
10884450275662
Brand
Merit PAK™
Company
Merit Medical Systems, Inc.
Model
00884450275665
Catalog number
PAKM5NPD4/A
Published
2020-04-09
Public version status
New
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
10884450275662PackageGS15In Commercial Distribution
00884450275665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445027566210884450275662
00884450275665008844502756658844502756650884450275665

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

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
00884450079973Merit Medical®Initial ReleaseK09-10089M2026-06-09
00884450101537Merit Medical®Initial ReleaseK09-143202026-06-09
00884450101568Merit Medical®Initial ReleaseK09-143212026-06-09
00884450435748SCOUT®MSG-012026-06-09
00884450486962Merit Medical®Initial ReleaseK09-144042026-06-09
00884450486993Merit Medical®Initial ReleaseK10-062032026-06-09
00884450767542SCOUT MD™BSSCMD-012026-06-09
00884450826560Fountain®BIS5-135-302026-06-09
10884450114008Prelude IDeal™HPID4F11018SS2026-06-09
10884450119799Prelude EASE™JPHR6F11021PW2026-06-09
00884450467572DuraMax®CH7871030281952026-06-08
00884450469033BioFlo DuraMax®BH9651030281612026-06-08
00884450469132BioFlo DuraMax®BH9651030282112026-06-08
00884450787663Impress®C44038STS2026-06-08
10884450114855Prelude IDeal™HPID5F16021PW2026-06-08
00884450030592Merit Medical®Initial ReleaseK08-02650A2026-06-06
00884450107072Merit Medical®Initial ReleaseK09-13880A2026-06-06
00884450110270Merit Drainage Depot™Initial ReleaseK10-03450A2026-06-06
00884450161746Merit Medical®Initial ReleaseK09-10859C2026-06-06
00884450376171One-Tie®ALR-OTE-N2026-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10884450008857Prelude®Merit Medical Systems, Inc.DRE2016-09-24
10884450008871Prelude®Merit Medical Systems, Inc.DRE2016-09-24
10884450008888Prelude®Merit Medical Systems, Inc.DRE2016-09-24
10884450008895Prelude®Merit Medical Systems, Inc.DRE2016-09-24
10884450008901Prelude®Merit Medical Systems, Inc.DRE2016-09-24