FDA.reportPublic FDA data

ARROW

Primary DI
10801902168853
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN916861
Catalog number
CV-45703-E
Device description
Arrowg+ard Blue Plus(R) Three-Lumen CVC
Published
2022-11-29
Public version status
Update
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
K993691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993691000ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERArrow Intl., Inc.2000-03-08FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902168850PackageGS110In Commercial Distribution
10801902168853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190216885020801902168850
1080190216885310801902168853

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterization kit, short-termA collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid excessive heat above 40C (104F).
Storage Environment Temperature025 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
Kit
true
Combination product
true
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
10801902227239ARROWIPNB00706ASK-04001-NYP22026-08-27
10801902227246ARROWIPNB00152ASK-29903-BSWH2026-08-27
14026704936011QUIKCLOT404040402026-08-27
14026704657169HUDSON RCIIPN91399432302019-05-09
14026704657176HUDSON RCIIPN91399532602019-05-09
04026704303090RUSCHIPN0512673181142016-09-16
04026704387793HUDSON RCIIPN04421532302016-09-16
04026704596430HUDSON RCIIPN04421632602016-09-16
05060112313851LMA AIRWAY MANAGEMENTIPN0478971920302018-09-15
10801902216486ARROWIPN928616EC-050002023-10-26
10801902216516ARROWIPN928618LR-055022023-10-26
10801902216523ARROWIPN928619LR-055032023-10-26
10841156111250GUIDELINERIPN93018852702025-07-14
14026704303448RUSCHIPN0505311807301402016-09-16
14026704303486RUSCHIPN0505351807301802016-09-16
14026704632869DEKNATELIPN0287367-9222019-09-04
14026704670472DEKNATELIPN914541X-4769W2020-05-27
14026704926944RUSCHIPN9297471807052602026-08-25
14026704926951RUSCHIPN9297481807052802026-08-25
14026704926968RUSCHIPN9297491807053002026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902227239ARROWTELEFLEX INCORPORATEDFOZ2026-08-27
10801902222951ARROWTELEFLEX INCORPORATEDFOZ2026-08-19
10801902222968ARROWTELEFLEX INCORPORATEDFOZ2026-08-19
10801902222975ARROWTELEFLEX INCORPORATEDFOZ2026-08-19
10801902226454ARROWTELEFLEX INCORPORATEDFOZ2026-08-10
10801902219210ARROWTELEFLEX INCORPORATEDFOZ2026-08-03
10801902130546ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902218084ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902218404ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902224436ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
00382903935314NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
10801902167344ARROWTELEFLEX INCORPORATEDFOZ2026-07-30
10801902129700ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902167351ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902167894ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902226379ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226386ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226140ARROWTELEFLEX INCORPORATEDFOZ2026-06-12
10801902226157ARROWTELEFLEX INCORPORATEDFOZ2026-06-12
10801902226164ARROWTELEFLEX INCORPORATEDFOZ2026-06-12
00850073657003Ruby Intravascular CatheterVenocare, Inc.FOZ2026-04-08
10801902219449ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
10192253040241ArgyleCardinal Health 200, LLCFOZ2025-01-08