FDA.reportPublic FDA data

Disposable IV Catheter

Primary DI
16941512151082
Brand
Disposable IV Catheter
Company
Shinva Ande Healthcare Apparatus Co., Ltd
Model
IVC09-26
Published
2023-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

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
K202060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202060000Disposable IV catheterShinva Ande Healthcare Apparatus Co., Ltd.2021-07-23FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36941512151086PackageGS150In Commercial Distribution
56941512151080PackageGS14In Commercial Distribution
16941512151082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3694151215108636941512151086
5694151215108056941512151080
1694151215108216941512151082

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral intravenous cannulaA short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.

Regulatory Flags#

DUNS number
421062164
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16941512150887Disposable IV CatheterIVC07-142023-05-08
16941512150894Disposable IV CatheterIVC07-162023-05-08
16941512150900Disposable IV CatheterIVC07-182023-05-08
16941512150917Disposable IV CatheterIVC07-202023-05-08
16941512150924Disposable IV CatheterIVC07-222023-05-08
16941512150931Disposable IV CatheterIVC07-242023-05-08
16941512150948Disposable IV CatheterIVC07-262023-05-08
16941512151020Disposable IV CatheterIVC09-142023-05-08
16941512151037Disposable IV CatheterIVC09-162023-05-08
16941512151044Disposable IV CatheterIVC09-182023-05-08
16941512151051Disposable IV CatheterIVC09-202023-05-08
16941512151068Disposable IV CatheterIVC09-222023-05-08
16941512151075Disposable IV CatheterIVC09-242023-05-08
36941512150881Disposable IV CatheterIVC07-142023-05-08
36941512150898Disposable IV CatheterIVC07-162023-05-08
36941512150904Disposable IV CatheterIVC07-182023-05-08
36941512150911Disposable IV CatheterIVC07-202023-05-08
36941512150928Disposable IV CatheterIVC07-222023-05-08
36941512150935Disposable IV CatheterIVC07-242023-05-08
36941512150942Disposable IV CatheterIVC07-262023-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08032248007123SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007130SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007147SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007154SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007161SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007178SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007185SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007192SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007208SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007215SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007222SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007239SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007246SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007253SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007260SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007277SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007284SOL CARE 1 DELTA MED SPAFOZ2021-03-30
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