FDA.reportPublic FDA data

ARROW

Primary DI
10801902187274
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN919438
Catalog number
CS-46702-E
Device description
Arrowg+ard Blue Plus(R) Two-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
20801902187271PackageGS15In Commercial Distribution
10801902187274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190218727120801902187271
1080190218727410801902187274

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 40 C (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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902228045ARROWAK-05503AK-055032026-10-09
10801902228052ARROWSJ-05501SJ-055012026-10-09
10801902228069ARROWAB-05060-PKAB-05060-PK2026-10-09
10801902228076ARROWMP-17019-TKLMP-17019-TKL2026-10-09
10801902228083ARROWAK-05560AK-055602026-10-09
10801902228090ARROWAK-05502AK-055022026-10-09
10801902228106ARROWAK-05501AK-055012026-10-09
10841156108526ONCONTROLIPN9190219461-VC-0062022-01-21
10841156108540ONCONTROLIPN9190239462-VC-0062021-10-29
10841156108588ONCONTROLIPN9190279464-VC-0062021-10-29
10841156108625ONCONTROLIPN9190319466-VC-0062021-10-29
14026704610904LMAIPN046748V1750152018-09-15
14026704610928LMAIPN046750V1750252018-09-15
14026704640277RUSCHIPN0499450044511002019-04-23
14026704641779RUSCHIPN0499380044311002019-04-24
14026704641793RUSCHIPN0499410044335002019-04-24
14026704641816RUSCHIPN0499430044490002019-04-24
14026704641823RUSCHIPN0499440044500502019-04-24
05060112311918LMAIPN046959V1250302018-09-15
10801902226119ARROWPR-45563-BASPR-45563-BAS2026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955874330INTROCAN SAFETY®B. BRAUN MEDICAL INC.FOZ2026-10-11
10801902226195ARROWTELEFLEX INCORPORATEDFOZ2026-09-28
10801902228205ARROWTELEFLEX INCORPORATEDFOZ2026-09-25
10801902228212ARROWTELEFLEX INCORPORATEDFOZ2026-09-25
10801902228717ARROWTELEFLEX INCORPORATEDFOZ2026-09-22
10801902227062ARROWTELEFLEX INCORPORATEDFOZ2026-09-03
10801902227079ARROWTELEFLEX INCORPORATEDFOZ2026-09-03
10801902227321ARROWTELEFLEX INCORPORATEDFOZ2026-08-31
10801902227338ARROWTELEFLEX INCORPORATEDFOZ2026-08-28
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