FDA.reportPublic FDA data

ARROW

Primary DI
30801902159039
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN914881
Catalog number
CA-24301
Device description
Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter
Published
2020-04-24
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
K900263000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K900263000ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERArrow Intl., Inc.1990-07-24FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30801902159039PackageGS110In Commercial Distribution
40801902159036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3080190215903930801902159039
4080190215903640801902159036

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterA sterile, flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature025 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
true
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704927910PILLINGIPN0079065068002026-07-08
10801902226171ARROWPR-45552-BASPR-45552-BAS2026-07-06
10841156112035LANGSTONIPN93901955402026-06-26
10801902218732ARROWIPN928981CS-15853-E2026-06-24
10801902221725ARROWIPN930533EC-055002026-06-24
14026704664983HUDSON RCIIPN039676158002026-06-24
14026704664990HUDSON RCIIPN039677158022026-06-24
14026704665003HUDSON RCIIPN039678158042026-06-24
14026704665027HUDSON RCIIPN039680158082026-06-24
14026704665034HUDSON RCIIPN039681158102026-06-24
14026704665164HUDSON RCIIPN03969412712026-06-24
14026704665171HUDSON RCIIPN03969512722026-06-24
14026704665195HUDSON RCIIPN03969712742026-06-24
14026704665201HUDSON RCIIPN03969812752026-06-24
14026704924254PLEUR-EVACIPN929357PE104-082026-06-24
15060112315029LMA AIRWAY MANAGEMENTIPN0487781280302026-06-24
15060112315036LMA AIRWAY MANAGEMENTIPN0487801280402026-06-24
15060112315043LMA AIRWAY MANAGEMENTIPN0487821280502026-06-24
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850073657003Ruby Intravascular CatheterVenocare, Inc.FOZ2026-04-08
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