FDA.reportPublic FDA data

IV Catheter

Primary DI
20853620005221
Brand
IV Catheter
Company
Merit Pharmaceutical
Model
035599853000
Published
2019-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10853620005224PackageGS150In Commercial Distribution
20853620005221PackageGS14In Commercial Distribution
00853620005227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085362000522410853620005224
2085362000522120853620005221
00853620005227008536200052278536200052270853620005227

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
093370369
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
true
Sterilization required before use
false

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
00853620005180IV Catheter0356625880002019-01-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08032248007246SOL CARE 1DELTA MED SPAFOZ2021-03-30
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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