FDA.reportPublic FDA data

IV Catheter

Primary DI
00853620005180
Brand
IV Catheter
Company
Merit Pharmaceutical
Model
035662588000
Published
2019-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071382000SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,Shinchang Medical Co., Ltd.2007-10-16FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853620005187PackageGS150In Commercial Distribution
20853620005184PackageGS14In Commercial Distribution
00853620005180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085362000518710853620005187
2085362000518420853620005184
00853620005180008536200051808536200051800853620005180

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular catheterA sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(323) 227-4831solutions@meritpharm.com

Regulatory Flags#

DUNS number
093370369
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853620005401"21G x 3/4 Safety Blood Collection 12"" Tubing"0233362621252019-01-01
00853620005418"23G x 3/4 Safety Blood Collection 12"" Tubing"0244412326872019-01-01
00853620005944Empty IV Bag 1000mL MIVB1000502025-10-13
00853620005173MeritPoint0444533040002019-01-01
00853620005241100cc Syringe0446436865002019-01-01
00853620005388200cc Syringe0446746097502019-01-01
00853620005227IV Catheter0355998530002019-01-01
008536200052343cc Syringe0445818400002019-01-01
008536200054561cc TB LL Syringe0422207630002019-01-01
0085362000546360cc Syringe0447055330002019-01-01
00853620005357Extension Set Regular Bore0887137230002019-01-01
00853620005203IV Set With In-Line Filter0363195710002019-01-01
00853620005210IV Set0360668440002019-01-01
00853620005272IV Administration Set0360668440002019-01-01
00853620005319IV Administration Set Needlefree0362112740002019-01-01
00853620005326IV Administration Set 15 Drop0360274330002019-01-01
00853620005333IV Administration Set 60 Drop0361062220002019-01-01
00853620005302Pressure Infuser 1000mL0996818425002019-01-01
00853620005296Blood Administration Set0255462032502019-01-01
00853620005289Pressure Infuser0996323650002019-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08032248007291SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248005372Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005389Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005396Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005402Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005419Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005426Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005433Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005440Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005457Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005464Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005471Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005495Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26