FDA.report

ARROW

Primary DI
20801902139348
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN038357
Catalog number
ASK-41541-SH
Device description
AM/AT PI MDL 1-L: 4.5FR X 15CM
Published
2018-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
PNDMidline catheter

Product Code Classifications

CodeDeviceSpecialtyClass
PNDMidline CatheterGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20801902139348PackageGS15Not in Commercial Distribution
10801902139341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080190213934820801902139348
1080190213934110801902139341

GMDN Terms

TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, 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 typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature25 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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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

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30849884007047VYGONVygon CorporationPND2025-09-25
30849884006941VYGONVygon CorporationPND2025-09-15
30849884007009VYGONVygon CorporationPND2025-09-05
30849884006996VYGONVygon CorporationPND2025-08-21
10801741236140ProvenaBard Access Systems, Inc.PND2025-08-20
10801741236157ProvenaBard Access Systems, Inc.PND2025-08-20
10801741236836PowerMidlineBard Access Systems, Inc.PND2025-08-20
10801741234849Provena MidlineBard Access Systems, Inc.PND2025-01-23
10801741234566PowerMidlineBard Access Systems, Inc.PND2024-12-09
10801741234597Provena MidlineBard Access Systems, Inc.PND2024-12-09
10801741232135PowerMidlineBard Access Systems, Inc.PND2024-09-27
10801741232142Bard PowerMidlineBard Access Systems, Inc.PND2024-09-27
10801741233224Provena MidlineBard Access Systems, Inc.PND2024-09-27
10801741233231Provena MidlineBard Access Systems, Inc.PND2024-09-27
10801741233248Provena MidlineBard Access Systems, Inc.PND2024-09-27
10801741233255Provena MidlineBard Access Systems, Inc.PND2024-09-27
20801902213062ARROWTELEFLEX INCORPORATEDPND2024-08-01
20801902213086ARROWTELEFLEX INCORPORATEDPND2024-08-01
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20801902218869ARROWTELEFLEX INCORPORATEDPND2024-01-29
20801902218852ARROWTELEFLEX INCORPORATEDPND2024-01-24
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10801741227544ProvenaBard Access Systems, Inc.PND2023-07-10
10801741226868PowerGlide STBard Access Systems, Inc.PND2023-07-05
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