Merit Medical®

Primary DI
10884450015299
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450015292
Catalog number
HVA-100
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
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073035000PRELUDE AND PRELUDE PRO SHEATH INTRODUCERSMerit Medical Systems, Inc.2007-11-20DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450015299PackageGS110In Commercial Distribution
00884450015292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445001529910884450015299
00884450015292008844500152928844500152920884450015292

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
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
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
00884450436745Merit Medical®Initial ReleaseK09-13832A2026-06-06
00884450220306Merit Medical®Initial ReleaseK12-126952026-06-03
00884450426630Merit Medical®Initial ReleaseK09-13283C2026-06-03
00884450437438Merit Medical®Initial ReleaseK09-14187A2026-06-03
00884450485651Merit Medical®Initial ReleaseK04-00404B2026-06-03
00884450486887Merit Medical®Initial ReleaseK09-07789R2026-06-03
00884450487006Merit Medical®Initial ReleaseK12-127222026-06-03
10884450706708Prelude®FPSI-4F-23-035MT2026-06-03
00884450424087Merit Medical®Initial ReleaseK09-13251A2026-06-02
00884450431009Merit Medical®Initial ReleaseK08-03026A2026-06-02

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
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07613327459227AXS VECTA 71Stryker CorporationDTL2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDTL2018-10-26
07613327459180AXS INFINITY LS PLUSStryker CorporationDTL2018-10-08
07613327459197AXS INFINITY LS PLUSStryker CorporationDTL2018-10-08
07613327459203AXS INFINITY LS PLUSStryker CorporationDTL2018-10-08
08714729965787WATCHDOG™BOSTON SCIENTIFIC CORPORATIONDTL2017-09-12
08714729071280GateWay™ PLUSBOSTON SCIENTIFIC CORPORATIONDTL2016-09-24
08714729295822NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
08714729295839NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
08714729295853NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
08714729375555NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
08714729734604GateWay™ PLUSBOSTON SCIENTIFIC CORPORATIONDTL2016-09-24
08714729742913NABOSTON SCIENTIFIC CORPORATIONDRE2016-09-24
H6714003510N/AUTAH MEDICAL PRODUCTS, INC.DTL2016-09-23
H6719026380N/AUTAH MEDICAL PRODUCTS, INC.DTL2016-09-23
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H787181002030AngioDynamicsANGIODYNAMICS, INC.DRE2016-09-20
H787181002040AngioDynamicsANGIODYNAMICS, INC.DRE2016-09-20
H965457480AngioDynamicsNAVILYST MEDICAL, INC.DRE2016-09-20
H965457490AngioDynamicsNAVILYST MEDICAL, INC.DRE2016-09-20
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H965457510AngioDynamicsNAVILYST MEDICAL, INC.DRE2016-09-20
H965457520AngioDynamicsNAVILYST MEDICAL, INC.DRE2016-09-20
H965457530AngioDynamicsNAVILYST MEDICAL, INC.DRE2016-09-20
H965457540AngioDynamicsNAVILYST MEDICAL, INC.DRE2016-09-20
H965457550AngioDynamicsNAVILYST MEDICAL, INC.DRE2016-09-20