FDA.reportPublic FDA data

ARROW

Primary DI
10801902130157
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN037697
Catalog number
CDC-41541-MPK1A
Device description
ARROW(R) Midline with Chlorag+ard(R) Technology
Published
2017-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNDMidline catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNDMidline CatheterGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161313000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161313000ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic TechnologyArrow International, Inc. (Subsidiary of Teleflex, Inc.)2016-08-24PND

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902130154PackageGS15Not in Commercial Distribution
10801902130157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190213015420801902130154
1080190213015710801902130157

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular catheterA sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. 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
Kit
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
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
00849884007589VYGONVygon CorporationPND2026-06-25
00801741240102ProvenaBard Access Systems, Inc.PND2026-06-24
36927675517273SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675517280SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675517297SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675517303SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675517310SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675519857SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675519864SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675520730SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675520747SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
36927675520754SURFLO MIDELATerumo Medical Products (Hangzhou) Co., Ltd.PND2026-04-01
10801902213065ARROWTELEFLEX INCORPORATEDPND2024-08-01
10801902213089ARROWTELEFLEX INCORPORATEDPND2024-08-01
10801902218862ARROWTELEFLEX INCORPORATEDPND2024-01-29
10801902218855ARROWTELEFLEX INCORPORATEDPND2024-01-24
10801902216820ARROWTELEFLEX INCORPORATEDPND2023-09-13
10801902216837ARROWTELEFLEX INCORPORATEDPND2023-09-13
10801902201482ARROWTELEFLEX INCORPORATEDPND2022-10-13
10801902201499ARROWTELEFLEX INCORPORATEDPND2022-10-13
10801902201505ARROWTELEFLEX INCORPORATEDPND2022-10-13
10801902205466ARROWTELEFLEX INCORPORATEDPND2022-09-30
10801902205473ARROWTELEFLEX INCORPORATEDPND2022-09-30
10801902205480ARROWTELEFLEX INCORPORATEDPND2022-06-03
10801902205497ARROWTELEFLEX INCORPORATEDPND2022-06-03
10801902188400ARROWTELEFLEX INCORPORATEDPND2021-12-14
10801902188417ARROWTELEFLEX INCORPORATEDPND2021-12-14
10801902189353ARROWTELEFLEX INCORPORATEDPND2021-04-05
00801741215674Provena MidlineBard Access Systems, Inc.PND2020-10-01
00801741213281Provena MidlineBard Access Systems, Inc.PND2020-07-20