FDA.reportPublic FDA data

ARROW

Primary DI
10801902130164
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN037698
Catalog number
CDC-41552-MPK1A
Device description
ARROW(R) Midline with Chlorag+ard(R) Technology
Published
2016-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
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
20801902130161PackageGS15Not in Commercial Distribution
10801902130164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190213016120801902130161
1080190213016410801902130164

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

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
Sterilization required before use
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
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