FDA.reportPublic FDA data

ARROW

Primary DI
20801902192633
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN920059
Catalog number
PR-35041-HPHNM
Device description
Pressure Injectable One-Lumen PICC with 80 cm Wire
Published
2022-11-08
Public version status
New
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
BSOCATHETER, CONDUCTION, ANESTHETIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSOCatheter, Conduction, AnestheticAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902192633PackageGS15In Commercial Distribution
10801902192636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190219263320801902192633
1080190219263610801902192636

GMDN Terms#

Term, Definition table
TermDefinition
Peripherally-inserted central venous catheterA thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

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
true
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
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223132210InfiltraLong 700Pajunk GmbH MedizintechnologieBSO2025-07-30
20801902223658ARROWTELEFLEX INCORPORATEDBSO2025-07-21
04048223128978E-Cath® Plus Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223128985E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223128992E-Cath® Plus Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129029E-Cath® Plus Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129043E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129067E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129074E-Cath® STIM Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129128E-Cath® Plus Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129166E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129258E-Cath® Plus Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129265E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129272E-Cath® Plus Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129289E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129333E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129388E-Cath® Plus Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129579InfiltraLongPajunk GmbH MedizintechnologieBSO2025-06-17
04048223129609InfiltraLong 500TPajunk GmbH MedizintechnologieBSO2025-06-17
04048223129623InfiltraLongPajunk GmbH MedizintechnologieBSO2025-06-17
04048223129661InfiltraLong 600TPajunk GmbH MedizintechnologieBSO2025-06-17
04048223129760InfiltraLongPajunk GmbH MedizintechnologieBSO2025-06-17
04048223129876E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223132180InfiltraLong 600Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223132203InfiltraLong 500Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223132227InfiltraLong 600TPajunk GmbH MedizintechnologieBSO2025-06-17
04048223132265InfiltraLong 900Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223132401InfiltraLong 420Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223132432InfiltraLong SonoPajunk GmbH MedizintechnologieBSO2025-06-17
04048223133187E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17