FDA.reportPublic FDA data

ARROW

Primary DI
20801902222248
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN930613
Catalog number
CDA-22122-CN1AU
Device description
Arrowg+ard Blue(R) You-Bend(TM) Two-Lumen Hemodialysis Catheterization for High Volume Infusions
Published
2025-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
20801902222248PackageGS15In Commercial Distribution
10801902222241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190222224820801902222248
1080190222224110801902222241

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
Special Storage Condition, Specify00Avoid excessive heat above 40C (104F).
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902223088ARROWTELEFLEX INCORPORATEDMPB2025-10-01
10801902223095ARROWTELEFLEX INCORPORATEDMPB2025-10-01
10801902222258ARROWTELEFLEX INCORPORATEDMPB2025-06-12
10801902222265ARROWTELEFLEX 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
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10801902213713ARROWTELEFLEX INCORPORATEDMPB2023-05-03
10801902213478ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213492ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213515ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213539ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213546ARROWTELEFLEX INCORPORATEDMPB2023-04-27