FDA.reportPublic FDA data

ARROW

Primary DI
10801902132823
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN037793
Catalog number
ASK-11142-JHL1
Device description
MAC KIT: 2-L 9 FR DISTAL
Published
2017-03-02
Public version status
Update
Distribution status
Not 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
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002507000TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORTArrow Intl., Inc.2001-03-21DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902132820PackageGS15Not in Commercial Distribution
10801902132823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190213282020801902132820
1080190213282310801902132823

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator and/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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
10801902210897ARROWIPN925094ASK-21142-HF52026-08-04
10801902210903ARROWIPN925095ASK-21142-SG22026-08-04
10801902210934ARROWIPN925098ASK-21242-SL12026-08-04
10801902227116ARROWIPNB00557ASK-29903-CFV2026-08-31
10801902227208ARROWIPNB00556ASK-29803-CFV2026-08-31
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
10801902226188ARROWIPNB00349SI-111422026-09-28
10801902226195ARROWIPNB00348SI-112422026-09-28
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902227109ARROWIPNB00297ASK-09601-CF2026-09-03
10801902227246ARROWIPNB00152ASK-29903-BSWH2026-08-27
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
10801902193114ARROWIPN920089CDC-29803-XCN1A2026-07-30
10801902193121ARROWIPN920090CDC-29803-XN1A2026-07-30
10801902193190ARROWIPN920097CDC-29903-XCN1A2026-07-30
10801902193206ARROWIPN920098CDC-29903-XN1A2026-07-30
10801902196184ARROWIPN920629EI-040602026-07-30
10801902196498ARROWIPN920660CDC-21142-XCN1A2026-07-30
10801902196511ARROWIPN920662CDC-21242-XCN1A2026-07-30
10801902196528ARROWIPN920663CDC-21242-XN1A2026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253040241ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040258ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040265ArgyleCardinal Health 200, LLCFOZ2025-01-08
10801902102901ARROWTELEFLEX INCORPORATEDFOZ2019-12-10
10801902130331ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902130355ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902130379ARROWTELEFLEX INCORPORATEDFOZ2017-11-30
10801902133004ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133028ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133042ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133066ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133080ARROWTELEFLEX INCORPORATEDFOZ2017-04-12
10801902133240ARROWTELEFLEX INCORPORATEDFOZ2017-03-14
10801902133233ARROWTELEFLEX INCORPORATEDFOZ2017-03-08
10801902133127ARROWTELEFLEX INCORPORATEDFOZ2017-03-07
10801902132816ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902133097ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902133103ARROWTELEFLEX INCORPORATEDFOZ2017-03-02
10801902131529ARROWTELEFLEX INCORPORATEDFOZ2017-02-17
10801902131512ARROWTELEFLEX INCORPORATEDFOZ2017-02-15
10801902131567ARROWTELEFLEX INCORPORATEDFOZ2017-02-15
00801741074769Excalibur Introducer SystemBard Access Systems, Inc.FOZ2017-02-03
00801741074783Excalibur Introducer SystemBard Access Systems, Inc.FOZ2017-02-03
10801902131178ARROWTELEFLEX INCORPORATEDFOZ2017-01-13
10801902130898ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130904ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130911ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130928ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902130935ARROWTELEFLEX INCORPORATEDFOZ2016-12-21
10801902129359ARROWTELEFLEX INCORPORATEDFOZ2016-11-11