FDA.reportPublic FDA data

Merit Medical®

Primary DI
20884450178960
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450178966
Catalog number
K08-00949
Published
2018-09-13
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
OJAIntravenous extension tubing set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJAIntravenous Extension Tubing SetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450178963PackageGS150In Commercial Distribution
20884450178960PackageGS14In Commercial Distribution
00884450178966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445017896310884450178963
2088445017896020884450178960
00884450178966008844501789668844501789660884450178966

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration setA collection of noninvasive devices designed to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use device.

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
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
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