FDA.report

Merit Medical®

Primary DI
20884450046641
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450046647
Catalog number
K04-00418
Published
2018-09-13
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

Related Records

Product Codes

CodeName
OJAIntravenous extension tubing set

Product Code Classifications

CodeDeviceSpecialtyClass
OJAIntravenous Extension Tubing SetGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450046644PackageGS125In Commercial Distribution
20884450046641PackageGS14In Commercial Distribution
00884450046647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445004664410884450046644
2088445004664120884450046641
00884450046647008844500466478844500466470884450046647

GMDN Terms

TermDefinition
Radiographic procedure tubingA flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).

Sterilization Methods

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 DIBrandModelCatalogPublished
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
10884450845223Merit Medical®D3339-312026-03-24
10884450027339Merit Medical®Initial ReleaseK04-01029A2026-03-20
10884450112721Merit Medical®Initial ReleaseK09-10994G2026-03-21
20884450164918Merit Medical®Initial ReleaseK09-12174B2026-03-21
10884450428532Merit Medical®Initial ReleaseK09-09762A2026-03-21
10884450430788Merit Medical®Initial ReleaseK10-05773A2026-03-21
10884450430856Merit Medical®Initial ReleaseK09-04213A2026-03-21
10884450440602Merit Medical®Initial ReleaseK09-11433M2026-03-21
20884450441514Merit Medical®Initial ReleaseK09-14148B2026-03-21
20884450441552Merit Medical®Initial ReleaseK12-12053B2026-03-21
10884450441784SteadySheath®BLR-TSS-13.02026-03-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10884450029364Merit Medical®Merit Medical Systems, Inc.OJA2026-03-24
10884450027339Merit Medical®Merit Medical Systems, Inc.OJA2026-03-20
20884450031234Merit Medical®Merit Medical Systems, Inc.OJA2026-03-19
20884450428188Merit Medical®Merit Medical Systems, Inc.OJA2026-03-14
10884450029203Merit Medical®Merit Medical Systems, Inc.OJA2026-03-13
10884450122560Merit Medical®Merit Medical Systems, Inc.OJA2026-03-13
20884450029668Merit Medical®Merit Medical Systems, Inc.OJA2026-03-12
20884450113688Merit Medical®Merit Medical Systems, Inc.OJA2026-03-10
20884450123458Merit Medical®Merit Medical Systems, Inc.OJA2026-03-04
20884450029262Merit Medical®Merit Medical Systems, Inc.OJA2026-03-03
10884450428884Merit Medical®Merit Medical Systems, Inc.OJA2026-03-03
10884450029807Merit Medical®Merit Medical Systems, Inc.OJA2026-02-28
10884450121778Merit Medical®Merit Medical Systems, Inc.OJA2026-02-28
20884450437340Merit Medical®Merit Medical Systems, Inc.OJA2026-02-19
10884450028169Merit Medical®Merit Medical Systems, Inc.OJA2026-02-18
10884450027384Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
20884450029019Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
10884450121396Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
10884450428631Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
10884450434199Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
10884450122287Merit Medical®Merit Medical Systems, Inc.OJA2026-02-06
10884450031183Merit Medical®Merit Medical Systems, Inc.OJA2026-02-05
20884450106260Merit Medical®Merit Medical Systems, Inc.OJA2026-02-05
10884450121969Merit Medical®Merit Medical Systems, Inc.OJA2026-02-03
20884450027183Merit Medical®Merit Medical Systems, Inc.OJA2026-01-30
20884450136823Merit Medical®Merit Medical Systems, Inc.OJA2026-01-30
20884450122024Merit Medical®Merit Medical Systems, Inc.OJA2026-01-28
10884450029272Merit Medical®Merit Medical Systems, Inc.OJA2026-01-27
20884450136809Merit Medical®Merit Medical Systems, Inc.OJA2026-01-24
10884450122034Merit Medical®Merit Medical Systems, Inc.OJA2026-01-23