FDA.reportPublic FDA data

ARROW

Primary DI
20801902099673
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN033088
Catalog number
CS-16123-F
Device description
Large-Bore Multi-Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter for High Volume Infusions
Published
2019-11-18
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
DQYCatheter, percutaneous
FOZCatheter, intravascular, therapeutic, short-term less than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K862056000
K970864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K862056000[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIPArrow Intl., Inc.1986-08-25DQY
K970864000ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSArrow Intl., Inc.1997-10-17FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902099673PackageGS15In Commercial Distribution
40801902099677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190209967320801902099673
4080190209967740801902099677

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French

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
false
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
10841495149457QUIKCLOT1831832026-07-17
10841495149464QUIKCLOT1831832026-07-17
10841495149471QUIKCLOT1881882026-07-17
10841495149488QUIKCLOT1881882026-07-17
10841495149495QUIKCLOT3743742026-07-17
10841495149501QUIKCLOT3743742026-07-17
10841495149518QUIKCLOT4584582026-07-17
10841495149549QUIKCLOT4594592026-07-17
10841495149563QUIKCLOT4604602026-07-17
10841495149587QUIKCLOT4614612026-07-17
10841495149600QUIKCLOT467Z467Z2026-07-17
10841495149624QUIKCLOT4874872026-07-17
14026704930644QUIKCLOT1831832026-07-17
14026704930651QUIKCLOT1831832026-07-17
14026704930668QUIKCLOT1881882026-07-17
14026704930675QUIKCLOT1881882026-07-17
14026704930682QUIKCLOT3743742026-07-17
14026704930699QUIKCLOT3743742026-07-17
14026704930705QUIKCLOT4584582026-07-17
14026704930729QUIKCLOT4594592026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902226379ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226386ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
00810024671885CPS Locator 3D, Small Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671892CPS Locator 3D, Medium Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671908CPS Locator 3D, Large Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671915CPS Locator 3D, Medium, Extra Long Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671922CPS Locator 3D, Large, Extra Long Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
008537990079308F Base Camp System 2.0 90cmROUTE 92 MEDICALDQY2026-07-08
10801902218732ARROWTELEFLEX INCORPORATEDDQY2026-06-24
00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
08718481740330Guidion ShortIMDS Operations B.V.DQY2026-06-01
08718481740347FlowGuideIMDS Operations B.V.DQY2026-06-01
00850073657003Ruby Intravascular CatheterVenocare, Inc.FOZ2026-04-08
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
00842429106563Balloon CatheterMicrovention, Inc.DQY2022-06-14
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