FDA.reportPublic FDA data

Merit Medical®

Primary DI
10884450565930
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450565933
Catalog number
K09-13567
Published
2021-04-08
Public version status
New
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
OEXCardiovascular catheter sheath introducer kit
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEXCardiovascular Catheter Sheath Introducer KitCardiovascular2
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450565930PackageGS110In Commercial Distribution
20884450565937PackageGS14In Commercial Distribution
00884450565933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445056593010884450565930
2088445056593720884450565937
00884450565933008844505659338844505659330884450565933

GMDN Terms#

Term, Definition table
TermDefinition
Contrast medium injection system administration setA collection of noninvasive devices designed to conduct fluids between a contrast medium injection system and a patient catheter for the delivery of a contrast medium and/or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of tubing with switches/valves and connectors to syringes/fluid/contrast medium injection system, and possibly a pressure transducer; it is typically made of plastic materials. This is a disposable device which may serve multiple patients before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00884450180082Merit Medical®Initial ReleaseK09-13310C2026-10-09
10884450614409Prelude®DPSI-4F-11-0252026-10-09
00884450031469Merit Medical®Initial ReleaseK09-02709B2026-10-07
00884450554883SCOUT®MSG-022026-10-07
00884450836316Performa®D7445-B72026-10-07
00884450376713Merit Medical®Initial ReleaseK09-08747L2026-10-06
00884450428344Merit Medical®Initial ReleaseK11-01422A2026-10-06
10884450438791Prelude® Short SheathBPSS-8F-4-018MT2026-10-06
00884450029756Merit Medical®Initial ReleaseK08-02280A2026-09-29
00884450421383Merit Medical®Initial ReleaseK09-09424A2026-09-29
00884450431917Merit Medical®Initial ReleaseK09-13874B2026-09-29
00884450436004Merit Medical®Initial ReleaseK12-05438A2026-09-29
00884450452974MAK-NV™DMAK-NV-0082026-09-29
00884450453339MAK-NV™DMAK-NV-0162026-09-29
00884450500002Merit Medical®Initial ReleaseK09-144152026-09-29
10884450119751Prelude EASE™JPHR6F11018SC2026-09-29
10884450280055Prelude®JPSI-4F-11-0182026-09-29
10884450415839Prelude®JPSI-7F-11-0182026-09-29
10884450439163Prelude IDeal™JPID6F11021SSC2026-09-29
10884450439187Prelude IDeal™JPID6F11021PW2026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956077348CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956137547CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956194632CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956471887CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956518421CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956538467CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956541672CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956554085CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956569362CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956575042CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956576957CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956581227CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956584372CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956586802CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956586987CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956587212CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956591783CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956596481CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599147CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599178CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599185CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599383CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599390CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599451CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956599802CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956600324CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956600348CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956600379CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956600560CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12
10198956601413CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-10-12