FDA.reportPublic FDA data

ARROW

Primary DI
20801902188414
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN919547
Catalog number
PR-41552-BAS
Device description
Pressure Injectable Arrowg+ard Blue Advance(R) One-Lumen Midline
Published
2021-12-14
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
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
20801902188414PackageGS15In Commercial Distribution
10801902188417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190218841420801902188414
1080190218841710801902188417

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid excessive heat above 30C (86F).
Storage Environment Temperature025 Degrees Celsius

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
true
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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00801741215728Provena MidlineBard Access Systems, Inc.PND2020-10-23
00801741215674Provena MidlineBard Access Systems, Inc.PND2020-10-01
00801741213281Provena MidlineBard Access Systems, Inc.PND2020-07-20
00801741213243Provena MidlineBard Access Systems, Inc.PND2020-05-18