FDA.reportPublic FDA data

Merit® Manifold

Primary DI
10884450034153
Brand
Merit® Manifold
Company
Merit Medical Systems, Inc.
Model
00884450034156
Published
2016-09-24
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
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450034153PackageGS125In Commercial Distribution
20884450034150PackageGS14In Commercial Distribution
00884450034156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445003415310884450034153
2088445003415020884450034150
00884450034156008844500341568844500341560884450034156

GMDN Terms#

Term, Definition table
TermDefinition
StopcockA general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. 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
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 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
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 DI, Brand, Company table
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
10841268110073Hemostasis Valve AdapterGALT MEDICAL CORP.DTL2026-01-19
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
10884450312459TRAM®PMerit Medical Systems, Inc.DTL2025-12-23
10884450787547Impress®Merit Medical Systems, Inc.DQO2025-12-23