FDA.reportPublic FDA data

NovaCath™

Primary DI
00887709121584
Brand
NovaCath™
Company
ICU MEDICAL, INC.
Model
220750
Catalog number
220750
Device description
NovaCath Integrated IV Catheter System 22G x 0.75in
Published
2021-07-15
Public version status
New
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
K120839000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120839000NOVACATH SECURE IV CATHETER SYSTEM-18GTangent Medical Technologies, Inc.2012-07-20FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887709121581PackageGS1100In Commercial Distribution
00887709121584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088770912158110887709121581
00887709121584008877091215848877091215840887709121584

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.

Contacts#

Phone, Email table
PhoneEmail
+1(866)829-9025customerservice@icumed.com

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709195131BivonaST26FN50NGF055N2026-06-08
10887709195148BivonaFT25LN30NGF157N2026-06-08
10887709195155BivonaFT26FN35NSF050N2026-06-08
10887709195162BivonaHT26FS45NGF051N2026-06-08
10887709195179BivonaFT26FN40NGF053N2026-06-08
10887709195186BivonaFT26FN35NGF054N2026-06-08
10887709195193BivonaFU26FN45NGF049N2026-06-08
10887709195209BivonaFT26FN60NGA046N2026-06-08
10887709195216BivonaFT26FN35NGE057N2026-06-08
10887709195223BivonaFT26FN30NGE056N2026-06-08
10887709195230BivonaFP26FN40NGC058N2026-06-08
10887709195247BivonaFT26FN35NSF059N2026-06-08
10887709195254BivonaFT26FN40NGE063N2026-06-08
10887709195261BivonaXT26FS60NGC064N2026-06-08
10887709195278BivonaFU26FN45NSF052N2026-06-08
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05

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