FDA.reportPublic FDA data

ARROW

Primary DI
10801902007299
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN035358
Catalog number
AU-25122-F
Device description
ARROWg+ard Blue(R) You-Bend(TM) Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions
Published
2017-08-30
Public version status
Update
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
20801902007296PackageGS15Not in Commercial Distribution
10801902007299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190200729620801902007296
1080190200729910801902007299

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
Length20Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid Freezing, 0 deg. C and excessive heat above 40 deg. C
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
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902167344ARROWIPN916986CA-22123-F2026-07-30
10801902190908ARROWIPN919754CC-04100-S2026-07-30
10801902192933ARROWIPN920077CDA-25122-U1A2026-07-30
10801902193114ARROWIPN920089CDC-29803-XCN1A2026-07-30
10801902193121ARROWIPN920090CDC-29803-XN1A2026-07-30
10801902193190ARROWIPN920097CDC-29903-XCN1A2026-07-30
10801902193206ARROWIPN920098CDC-29903-XN1A2026-07-30
10801902193527ARROWIPN920130CS-15242-SPM2026-07-30
10801902193619ARROWIPN920140CS-15232-VFIM2026-07-30
10801902193626ARROWIPN920141CS-15232-VF2026-07-30
10801902193633ARROWIPN920142CS-15232-VFM2026-07-30
10801902193688ARROWIPN920131CS-15282-SPM2026-07-30
10801902194463ARROWIPN920404CS-15232-VFI2026-07-30
10801902196184ARROWIPN920629EI-040602026-07-30
10801902196498ARROWIPN920660CDC-21142-XCN1A2026-07-30
10801902196511ARROWIPN920662CDC-21242-XCN1A2026-07-30
10801902196528ARROWIPN920663CDC-21242-XN1A2026-07-30
10801902197716ARROWIPN920778JC-05400-E2026-07-30
10801902198461ARROWIPN920836PW-18080-HN2026-07-30
10801902200768ARROWIPN921145CL-078352026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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