FDA.reportPublic FDA data

ARROW

Primary DI
40801902123228
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN036408
Catalog number
ASK-04001-CG1
Device description
PICC Access Tray
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJTPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJTPort & Catheter, Implanted, Subcutaneous, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003006000TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTIONArrow Intl., Inc.2000-10-27LJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40801902123228PackageGS15In Commercial Distribution
10801902123227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4080190212322840801902123228
1080190212322710801902123227

GMDN Terms#

Term, Definition table
TermDefinition
Arterial/central venous catheterization support/maintenance kitA collection of sterile devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance. It is primarily intended to be used at the patient’s bedside and includes devices intended to support catheter placement and/or or ongoing maintenance (e.g., dressing change, catheter flushing) such as: disposable drapes, disinfectant wipes, dressings, gown, tourniquets, ultrasound system transducer cover, coupling gel, sharps container, syringe, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between 20 - 25°C (68 - 77°F). Excursions permitted to 15 - 30°C (59 - 86°F). Protect from freezing.
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
false
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
15051684018654BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018661BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018678BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018685BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018715BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018722BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018739BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018760BioFloAngiodynamics, Inc.LJT2024-09-20
15051684018791XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018814XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018838XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018883XcelaAngiodynamics, Inc.LJT2024-09-20
15051684018906XcelaAngiodynamics, Inc.LJT2024-09-20
15051684017978Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684017992Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018012Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018036Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018043Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018050Smart Port CTANGIODYNAMICS, INC.LJT2024-07-23
15051684018067Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018111Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018128Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018166Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018173Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018074Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018142Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018180Smart Port CTAngiodynamics, Inc.LJT2024-07-23
15051684018029Smart Port CTAngiodynamics, Inc.LJT2024-06-11
15051684018197Smart Port CTAngiodynamics, Inc.LJT2024-03-13
10801902189612ARROWTELEFLEX INCORPORATEDLJT2022-04-04