FDA.reportPublic FDA data

ARROW

Primary DI
10801902213713
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN927363
Catalog number
CDC-25142-XCN1A-C
Device description
Arrowg+ard Blue(R) Two-Lumen Hemodialysis Catheterization for High Volume Infusions
Published
2023-05-03
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
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
20801902213710PackageGS15In Commercial Distribution
10801902213713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190221371020801902213710
1080190221371310801902213713

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902172065ARROWIPN917285IAP-07002021-09-27
10801902187649ARROWIPN919474CS-12123-F2022-11-29
10801902215229ARROWIPN928089CS-12123-F2023-06-05
14026704633002DEKNATELIPN02854479-5562019-09-03
14026704633019DEKNATELIPN02854579-5602019-09-04
14026704633026DEKNATELIPN02854679-5982019-09-04
14026704633149DEKNATELIPN02855779-7752019-09-04
14026704633156DEKNATELIPN02855879-8122019-09-04
14026704633729DEKNATELIPN028759RC6-9702019-09-04
14026704633828DEKNATELIPN028581X-21612019-09-04
14026704633842DEKNATELIPN028658X-29722019-09-03
14026704633873DEKNATELIPN028583X-30192019-09-04
14026704633880DEKNATELIPN028763X-30272019-09-04
14026704633897DEKNATELIPN028764X-30942019-09-04
14026704633910DEKNATELIPN028584X-31422019-09-04
14026704633934DEKNATELIPN028766X-33412019-09-04
14026704633996DEKNATELIPN028769X-36342019-09-04
14026704634047DEKNATELIPN028773X-41942019-09-04
14026704634108DEKNATELIPN028661X-44342019-09-04
14026704634399DEKNATELIPN028776X-48842019-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902222876ARROWTELEFLEX INCORPORATEDMPB2026-08-18
10801902222906ARROWTELEFLEX INCORPORATEDMPB2026-08-18
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
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
10801902213706ARROWTELEFLEX INCORPORATEDMPB2023-05-03