FDA.reportPublic FDA data

ARROW

Primary DI
10801902168662
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN916842
Catalog number
RHY-100-ECGB-1
Device description
VPS Rhythm(R) ECG Lead IEC
Published
2020-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJSCatheter, intravascular, therapeutic, long-term greater than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160925000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160925000VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.)2016-12-22LJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801902168662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080190216866210801902168662

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheter navigation system control unitA portable mains electricity (AC-powered) component of an electrocardiographic central venous catheter navigation system intended to process and display electrocardiographic (ECG) data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC)]. It is a control unit with a monitor (e.g., a dedicated touchscreen unit) intended to be connected to the appropriate ECG cables/leads/catheter (not included). The technique involves the catheter functioning as an intravascular ECG electrode (using the guidewire or intraluminal saline as a conductor) which, along with skin surface ECG data, provides feedback on catheter tip location.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704936882WECK5442345442342026-10-20
14026704936899WECK5442445442442026-10-20
14026704936905WECK5442545442542026-10-20
14026704936912WECK5442325442322026-10-20
14026704936929WECK5442425442422026-10-20
14026704936936WECK5442525442522026-10-20
14026704936943WECK5442325442322026-10-20
14026704936950WECK5442345442342026-10-20
14026704936967WECK5442425442422026-10-20
14026704936974WECK5442445442442026-10-20
14026704936981WECK5442525442522026-10-20
14026704936998WECK5442545442542026-10-20
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741241024PowerPICC Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-10-21
00801741241031PowerPICC Provena Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-10-21
00801741241048PowerPICC Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-10-21
00886333209859L-Cath PICCARGON MEDICAL DEVICES, INC.LJS2026-10-14
10801902226119ARROWTELEFLEX INCORPORATEDLJS2026-10-07
10801902225907ARROWTELEFLEX INCORPORATEDLJS2026-10-06
10801902225631ARROWTELEFLEX INCORPORATEDLJS2026-08-18
10801902192025ARROWTELEFLEX INCORPORATEDLJS2026-07-29
10801902194364ARROWTELEFLEX INCORPORATEDLJS2026-07-29
10801902213188ARROWTELEFLEX INCORPORATEDLJS2026-07-23
10801902226171ARROWTELEFLEX INCORPORATEDLJS2026-07-06
00801741235207PowerPICCBard Access Systems, Inc.LJS2026-06-24
00801741235214PowerPICC ProvenaBard Access Systems, Inc.LJS2026-06-24
00801741240034PowerPICC SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240041PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240058PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
00860002238500Piccolo MedicalPiccolo Medical, Inc.LJS2026-05-06
00884908185386Vascu-PICC®Medical Components, Inc.LJS2025-11-20
00860002238531Piccolo MedicalPiccolo Medical, Inc.LJS2025-11-07
00860002238586Piccolo MedicalPiccolo Medical, Inc.LJS2025-11-07
10192253040241ArgyleCardinal Health 200, LLCLJS2025-01-08
10192253040258ArgyleCardinal Health 200, LLCLJS2025-01-08
10192253040265ArgyleCardinal Health 200, LLCLJS2025-01-08
20801902198086ARROWTELEFLEX INCORPORATEDLJS2022-12-01
H787MRC3S9110AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9200AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3S9210AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
H787MRC3R0001C3 WAVE SYSTEMANGIODYNAMICS, INC.LJS2022-04-08