FDA.reportPublic FDA data

Merit Maestro®

Primary DI
00884450478134
Brand
Merit Maestro®
Company
Merit Medical Systems, Inc.
Model
G
Catalog number
28MC28130SN
Published
2024-08-14
Public version status
Update
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
DXTInjector And Syringe, Angiographic
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2
KRACatheter, Continuous FlushCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450478134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450478134008844504781348844504781340884450478134

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). 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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450392898SCOUT MD™Initial ReleaseMDS10A-012026-05-23
00884450392904SCOUT MD™Initial ReleaseMDS10B-012026-05-23
00884450392911SCOUT MD™Initial ReleaseMDS10C-012026-05-23
00884450393383SCOUT MD™Initial ReleaseMDS75SA-012026-05-23
00884450399965SCOUT MD™Initial ReleaseMDS75SM-012026-05-23
00884450435120Merit Medical®Initial ReleaseK09-10345A2026-05-22
00884450435533Merit Medical®Initial ReleaseK07-00112C2026-05-23
00884450437049Merit Medical®Initial ReleaseK11-01136C2026-05-23
00884450437162Merit Medical®Initial ReleaseK09-10786C2026-05-22
00884450441350Merit Medical®Initial ReleaseK09-14004B2026-05-23
00884450474587Merit Medical®Initial ReleaseK12T-127142026-05-23
00884450392928SCOUT MD™Initial ReleaseMDS10M-012026-05-21
00884450394427SCOUT MD™Initial ReleaseMDS75SB-012026-05-21
00884450399170SCOUT MD™Initial ReleaseMDS75SC-012026-05-21
00884450436066Merit Medical®Initial ReleaseK08-02870A2026-05-21
00884450436172Merit Medical®Initial ReleaseK09-14009A2026-05-21
00884450122679Merit Medical®Initial ReleaseK08-02092B2026-05-20
00884450180075Merit Medical®Initial ReleaseK09-13303A2026-05-20
00884450424636Merit Medical®Initial ReleaseK09-13719B2026-05-20
00884450437988Merit Disposal Depot™Initial ReleaseK10-00577B2026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
07640132622690M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622706M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622157M-CATH MicrocatheterAcrostak (Schweiz) AGKRA2018-05-15
08714729235118Renegade™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729235125Renegade™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280583Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280590Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280606Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280613Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280620Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280637Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280644Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280651Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280668Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280736Renegade™ HI-FLO™ KitBOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280743Renegade™ HI-FLO™ KitBOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280750Renegade™ HI-FLO™ KitBOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280767Renegade™ HI-FLO™ KitBOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280774Renegade™ HI-FLO™ KitBOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280781Renegade™ HI-FLO™ KitBOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729301110Renegade™ - 18BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729301127Renegade™ - 18BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729322832Renegade™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729767497Neuro Renegade® Hi-Flo™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729767503Neuro Renegade® Hi-Flo™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729767510Neuro Renegade® Hi-Flo™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729767527Neuro Renegade® Hi-Flo™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729790815Renegade™ HI-FLO™ FATHOM™ SystemBOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729790822Renegade™ HI-FLO™ FATHOM™ SystemBOSTON SCIENTIFIC CORPORATIONKRA2016-09-24