FDA.report

Impress®

Primary DI
10884450698355
Brand
Impress®
Company
Merit Medical Systems, Inc.
Model
00884450698358
Catalog number
56538VER-H/B
Published
2023-05-04
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

Related Records

Product Codes

CodeName
DQOCatheter, intravascular, diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450698355PackageGS15In Commercial Distribution
00884450698358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445069835510884450698355
00884450698358008844506983588844506983580884450698358

GMDN Terms

TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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 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
10884450029364Merit Medical®Initial ReleaseK08-02142B2026-03-24
10884450111731Merit Medical®Initial ReleaseK09-11186D2026-03-24
00884450220696Merit Medical®Initial ReleaseK05T-02138B2026-03-24
10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10884450788407Impress®Merit Medical Systems, Inc.DQO2026-03-21
10884450787080Impress®Merit Medical Systems, Inc.DQO2026-03-19
50690103218607SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
10884450710729Impress®Merit Medical Systems, Inc.DQO2026-03-11
20841156111486LANGSTONTELEFLEX INCORPORATEDDQO2026-03-11
10884450787103Impress®Merit Medical Systems, Inc.DQO2026-03-03
10884450787455Impress®Merit Medical Systems, Inc.DQO2026-03-03
10884450788070Impress®Merit Medical Systems, Inc.DQO2026-02-19
10884450787653Impress®Merit Medical Systems, Inc.DQO2026-02-14
10884450852849Impress®Merit Medical Systems, Inc.DQO2026-02-14
50690103000417SWAN-GANZEdwards Lifesciences LLCDQO2026-01-30
00884450722329Impress®Merit Medical Systems, Inc.DQO2026-01-28
10884450787516Impress®Merit Medical Systems, Inc.DQO2026-01-23
10884450788124Impress®Merit Medical Systems, Inc.DQO2026-01-23
10884450787059Impress®Merit Medical Systems, Inc.DQO2026-01-22
10884450787837Impress®Merit Medical Systems, Inc.DQO2026-01-22
04987350744487DUALVIEWTERUMO CORPORATIONDQO2026-01-21
10884450787271Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450787530Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450788797Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450787721Impress®Merit Medical Systems, Inc.DQO2026-01-13
10884450787745Impress®Merit Medical Systems, Inc.DQO2026-01-13
10884450787707Impress®Merit Medical Systems, Inc.DQO2026-01-03
10884450787752Impress®Merit Medical Systems, Inc.DQO2026-01-03
10884450835934Performa®Merit Medical Systems, Inc.DQO2026-01-03
10884450787813Impress®Merit Medical Systems, Inc.DQO2025-12-24
10884450787820Impress®Merit Medical Systems, Inc.DQO2025-12-24
10884450787547Impress®Merit Medical Systems, Inc.DQO2025-12-23
10884450788650Impress®Merit Medical Systems, Inc.DQO2025-12-23
10884450787387Impress®Merit Medical Systems, Inc.DQO2025-12-20