FDA.reportPublic FDA data

ARROW

Primary DI
10801902222265
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN930615
Catalog number
CDC-22122-CN1AU
Device description
Arrowg+ard Blue(R) You-Bend(TM) Two-Lumen Hemodialysis Catheterization for High Volume Infusions
Published
2025-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MPBCatheter, hemodialysis, non-implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPBCatheter, Hemodialysis, Non-ImplantedGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993933000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K99393300014 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PROArrow Intl., Inc.2000-09-14MPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902222262PackageGS15In Commercial Distribution
10801902222265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190222226220801902222262
1080190222226510801902222265

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 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
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
10801902192933ARROWTELEFLEX INCORPORATEDMPB2026-07-30
10801902198492ARROWTELEFLEX INCORPORATEDMPB2026-07-29
10801902198508ARROWTELEFLEX INCORPORATEDMPB2026-07-29
10801902192926ARROWTELEFLEX INCORPORATEDMPB2026-07-27
10801902225518ARROWTELEFLEX INCORPORATEDMPB2026-03-11
10801902223088ARROWTELEFLEX INCORPORATEDMPB2025-10-01
10801902223095ARROWTELEFLEX INCORPORATEDMPB2025-10-01
10801902222258ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222272ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222296ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222302ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222319ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222241ARROWTELEFLEX INCORPORATEDMPB2025-06-10
10801902221923ARROWTELEFLEX INCORPORATEDMPB2025-05-13
10801902222487ARROWTELEFLEX INCORPORATEDMPB2025-04-04
10801902222494ARROWTELEFLEX INCORPORATEDMPB2025-04-04
10801902202410ARROWTELEFLEX INCORPORATEDMPB2024-09-06
10801902202427ARROWTELEFLEX INCORPORATEDMPB2024-09-06
10853072007173Dual Lumen Extended Length Catheter (15cm)Nuwellis Inc.MPB2024-02-20
10853072007210Dual Lumen Extended Length Catheter (11cm) and GALT Insertion KitNuwellis Inc.MPB2024-02-20
10853072007234Dual Lumen Extended Length Catheter (15cm) and GALT Insertion KitNuwellis Inc.MPB2024-02-20
10801902213638ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213652ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213676ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213683ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213690ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213706ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213713ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213478ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213492ARROWTELEFLEX INCORPORATEDMPB2023-04-27