FDA.reportPublic FDA data

ARROW

Primary DI
10801902096521
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN030107
Catalog number
CS-22122-F
Device description
Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter for High Volume Infusions
Published
2018-08-27
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
20801902096528PackageGS15Not in Commercial Distribution
10801902096521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190209652820801902096528
1080190209652110801902096521

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Length16Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store below 25°C (77°F). Avoid excessive heat above 40°C (104°F).
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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704927910PILLINGIPN0079065068002026-07-08
10801902226171ARROWPR-45552-BASPR-45552-BAS2026-07-06
10841156112035LANGSTONIPN93901955402026-06-26
10801902218732ARROWIPN928981CS-15853-E2026-06-24
10801902221725ARROWIPN930533EC-055002026-06-24
14026704664983HUDSON RCIIPN039676158002026-06-24
14026704664990HUDSON RCIIPN039677158022026-06-24
14026704665003HUDSON RCIIPN039678158042026-06-24
14026704665027HUDSON RCIIPN039680158082026-06-24
14026704665034HUDSON RCIIPN039681158102026-06-24
14026704665164HUDSON RCIIPN03969412712026-06-24
14026704665171HUDSON RCIIPN03969512722026-06-24
14026704665195HUDSON RCIIPN03969712742026-06-24
14026704665201HUDSON RCIIPN03969812752026-06-24
14026704924254PLEUR-EVACIPN929357PE104-082026-06-24
15060112315029LMA AIRWAY MANAGEMENTIPN0487781280302026-06-24
15060112315036LMA AIRWAY MANAGEMENTIPN0487801280402026-06-24
15060112315043LMA AIRWAY MANAGEMENTIPN0487821280502026-06-24
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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10801902213515ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213539ARROWTELEFLEX INCORPORATEDMPB2023-04-27
10801902213546ARROWTELEFLEX INCORPORATEDMPB2023-04-27