FDA.report

ARROW

Primary DI
00801902201492
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN921958
Catalog number
CDC-41541-MPK
Device description
Pressure Injectable Arrowg+ard Blue Advance(R) One-Lumen Midline
Published
2022-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
00801902201492PackageGS15In Commercial Distribution
10801902201499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00801902201492008019022014928019022014920801902201492
1080190220149910801902201499

GMDN Terms

TermDefinition
Peripheral intravenous catheterization kitA collection of devices intended for the introduction of an included peripheral vein cannula, often referred to as a catheter, to enable short-term (= 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. In addition to the cannula, it includes non-dedicated devices intended to support the procedure [e.g., tourniquet, swabs, dressings, disinfectants (e.g., alcohol), tape, gloves]. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

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 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 DIBrandCompanyProduct codePublished
50884908185718CT MIDLINE CATHETERMedical Components, Inc.PND2026-01-15
30849884007030VYGONVygon CorporationPND2025-09-26
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
1085004236505920G 8CM Stiletto Extended Dwell CatheterAvia Vascular, LLCPND2024-06-25
0085005184200120G 8CM Stiletto Extended Dwell CatheterSlipstream Medical, LLCPND2024-02-05
20801902218869ARROWTELEFLEX INCORPORATEDPND2024-01-29
20801902218852ARROWTELEFLEX INCORPORATEDPND2024-01-24
10801741226943PowerMidlineBard Access Systems, Inc.PND2023-09-19
20801902216827ARROWTELEFLEX INCORPORATEDPND2023-09-13
20801902216834ARROWTELEFLEX INCORPORATEDPND2023-09-13
10801741227544ProvenaBard Access Systems, Inc.PND2023-07-10
10801741226868PowerGlide STBard Access Systems, Inc.PND2023-07-05
10801741226875PowerGlide STBard Access Systems, Inc.PND2023-07-05