FDA.reportPublic FDA data

ARROW

Primary DI
20801902190110
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN919696
Catalog number
CV-15122-FBZ
Device description
Two-Lumen Hemodialysis Catheter for High Volume Infusions
Published
2022-11-29
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
K895417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K895417000ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KITArrow Intl., Inc.1990-01-03LFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902190110PackageGS15In Commercial Distribution
10801902190113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190219011020801902190110
1080190219011310801902190113

GMDN Terms#

Term, Definition table
TermDefinition
Double-lumen haemodialysis catheter, nonimplantableA flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device.

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
true
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
00801902002266ARROWIPN000082AI-071342016-09-16
00801902003362ARROWIPN035388CC-017002026-08-03
00850921007417ARROWIPN919634DLX-200-USC2026-08-03
04026704916955RUSCHIPN9007315640002026-08-03
04026704934812TELEFLEXIPN931133ST192026-08-03
05060112310058LMA AIRWAY MANAGEMENTIPN9016471000152026-08-03
05060112310065LMA AIRWAY MANAGEMENTIPN9016491000202026-08-03
05060112310607LMA AIRWAY MANAGEMENTIPN9018611500152026-08-03
10801902170191ARROWIPN917307CS-017012026-08-03
10801902206241ARROWIPN922981PW-18080-HS2026-08-03
10801902215168ARROWIPN9280309001T-VC-0052026-08-03
10801902219210ARROWIPN929382CV-15123-F2026-08-03
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
14026704730466PILLINGIPN924356P358PRA2026-08-03
14026704934758LMA AIRWAY MANAGEMENTIPN9292541360652026-08-03
14026704934765LMA AIRWAY MANAGEMENTIPN9292561360752026-08-03
14026704934772LMA AIRWAY MANAGEMENTIPN9292571360802026-08-03
14026704934802LMA AIRWAY MANAGEMENTIPN9292551360702026-08-03
00801902004857ARROWIPN033843AK-040202016-09-16
05060112310041LMA AIRWAY MANAGEMENTIPN9016451000102026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850073657003Ruby Intravascular CatheterVenocare, Inc.FOZ2026-04-08
10884521832930MAHURKARMozarc Medical US LLCFOZ2022-11-03
10884521832985MAHURKARMozarc Medical US LLCFOZ2022-11-03
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