FDA.reportPublic FDA data

MAK-NV™

Primary DI
00884450820667
Brand
MAK-NV™
Company
Merit Medical Systems, Inc.
Model
C
Catalog number
MAK-NV-019
Published
2026-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCBNEEDLE, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCBNeedle, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450820664PackageGS110In Commercial Distribution
00884450820667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445082066410884450820664
00884450820667008844508206678844508206670884450820667

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

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
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
10810068811084MONARCH™ Kit Catheter & AccessoriesAuris Health, Inc.GCB2026-05-05
10810068811060MONARCH™Guided Percutaneous Access KitAuris Health, Inc.GCB2026-05-04
00661392008960LSL HEALTHCARELSL Industries, LLCGCB2025-10-30
10841156111830TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111847TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111854TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
10841156111861TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111837TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111844TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111851TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
20841156111868TELEFLEXTELEFLEX INCORPORATEDGCB2025-09-24
14026704920263PILLINGTELEFLEX INCORPORATEDGCB2024-07-15
14026704920270PILLINGTELEFLEX INCORPORATEDGCB2024-07-15
00884450820643MAK-NV™Merit Medical Systems, Inc.GCB2024-06-28
10884450820640MAK-NV™Merit Medical Systems, Inc.GCB2024-06-28
00884450820568MAK-NV™Merit Medical Systems, Inc.GCB2024-06-18
10884450820565MAK-NV™Merit Medical Systems, Inc.GCB2024-06-18
00884450820612MAK-NV™Merit Medical Systems, Inc.GCB2024-06-15
10884450820619MAK-NV™Merit Medical Systems, Inc.GCB2024-06-15
00884450820636MAK-NV™Merit Medical Systems, Inc.GCB2024-06-12
10884450820633MAK-NV™Merit Medical Systems, Inc.GCB2024-06-12
10381780538493MicroFrance®INTEGRA MICROFRANCEGCB2024-05-29
10841156110949TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110956TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110963TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
10841156110970TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
20841156110946TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
20841156110953TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
20841156110960TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08
20841156110977TELEFLEXTELEFLEX INCORPORATEDGCB2024-04-08