FDA.reportPublic FDA data

Central venous catheter navigation system control unit

Definition
A 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.
GUDID devices
57
Last updated
2026-08-01 06:05:09

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10801902213188ARROWTELEFLEX INCORPORATEDIPN9271882026-07-23
00860002238517Piccolo MedicalPiccolo Medical, Inc.FGN-15-6342025-11-07
00860002238524Piccolo MedicalPiccolo Medical, Inc.FGN-15-7792025-11-19
00860002238548Piccolo MedicalPiccolo Medical, Inc.FGN-15-6942025-11-07
10801902114522ARROWTELEFLEX INCORPORATEDIPN0373422017-03-30
10801902114539ARROWTELEFLEX INCORPORATEDIPN0373432017-03-30
10801902114652ARROWTELEFLEX INCORPORATEDIPN0373712017-03-30
10801902124781ARROWTELEFLEX INCORPORATEDIPN0373752017-03-30
10801902125221ARROWTELEFLEX INCORPORATEDIPN0374032018-06-19
10801902125238ARROWTELEFLEX INCORPORATEDIPN0374042018-06-19
10801902125245ARROWTELEFLEX INCORPORATEDIPN0374052018-05-31
10801902125948ARROWTELEFLEX INCORPORATEDIPN0373622017-03-30
10801902145779ARROWTELEFLEX INCORPORATEDIPN0397732019-04-10
10801902158335ARROWTELEFLEX INCORPORATEDIPN9148362019-07-18
10801902163339ARROWTELEFLEX INCORPORATEDIPN9157082022-11-29
10801902195903ARROWTELEFLEX INCORPORATEDIPN9206002022-11-08
10801902195910ARROWTELEFLEX INCORPORATEDIPN9206012022-11-08
10801902209341ARROWTELEFLEX INCORPORATEDIPN9185302022-12-16
10801902209365ARROWTELEFLEX INCORPORATEDIPN9185322022-12-16
10801902219357ARROWTELEFLEX INCORPORATEDIPN9294552024-05-31
10801902219364ARROWTELEFLEX INCORPORATEDIPN9294562024-05-31
10801902222364ARROWTELEFLEX INCORPORATEDDLX-200-MTRB2025-10-22
10801902222371ARROWTELEFLEX INCORPORATEDDLX-200-TP2025-10-22
10801902222388ARROWTELEFLEX INCORPORATEDDLX-200-RC2025-10-07
10801902222395ARROWTELEFLEX INCORPORATEDDLX-200-ECGPC2025-10-07
10801902222418ARROWTELEFLEX INCORPORATEDDLX-200-MTRB-R2025-10-22
10801902222425ARROWTELEFLEX INCORPORATEDDLX-200-TP-R2025-10-22
10801902223750ARROWTELEFLEX INCORPORATEDIPN9309532025-10-02
10801902222401ARROWTELEFLEX INCORPORATEDIPN9306762025-10-02
03660812159852PILOT TLSMEDWIN FRANCE12025-06-27
20801902219361ARROWTELEFLEX INCORPORATEDIPN9294562024-05-31
30801902219351ARROWTELEFLEX INCORPORATEDIPN9294552024-05-31
20801902209362ARROWTELEFLEX INCORPORATEDIPN9185322022-12-16
10801902211917ARROWTELEFLEX INCORPORATEDIPN9182002023-11-29
20801902209348ARROWTELEFLEX INCORPORATEDIPN9185302022-12-16
20801902163336ARROWTELEFLEX INCORPORATEDIPN9157082022-11-29
20801902195900ARROWTELEFLEX INCORPORATEDIPN9206002022-11-08
20801902195917ARROWTELEFLEX INCORPORATEDIPN9206012022-11-08
20801902125235ARROWTELEFLEX INCORPORATEDIPN0374042018-06-19
10801902114607ARROWTELEFLEX INCORPORATEDIPN0373502017-03-30
10801902168655ARROWTELEFLEX INCORPORATEDIPN9168412020-07-29
10801902168662ARROWTELEFLEX INCORPORATEDIPN9168422020-07-29
10801902127898ARROWTELEFLEX INCORPORATEDIPN0375132017-03-30
H787471400CelerityNAVILYST MEDICAL, INC.H7874714002015-10-19
H787471440CelerityNAVILYST MEDICAL, INC.H7874714402015-10-19
H787471450CelerityNAVILYST MEDICAL, INC.H7874714502015-10-19
H787471460CelerityNAVILYST MEDICAL, INC.H7874714602015-10-19
H787471470CelerityNAVILYST MEDICAL, INC.H7874714702015-10-19
10801902127881ARROWTELEFLEX INCORPORATEDIPN0375122017-03-30
20801902127895ARROWTELEFLEX INCORPORATEDIPN0375132017-03-30
10801902114614ARROWTELEFLEX INCORPORATEDIPN0373512017-03-30
10801902124798ARROWTELEFLEX INCORPORATEDIPN0373762017-03-30
20801902114659ARROWTELEFLEX INCORPORATEDIPN0373712017-03-30
20801902125945ARROWTELEFLEX INCORPORATEDIPN0373622017-03-30
10801902114638ARROWTELEFLEX INCORPORATEDIPN0373612017-03-30
20801902125228ARROWTELEFLEX INCORPORATEDIPN0374032018-06-19
20801902125242ARROWTELEFLEX INCORPORATEDIPN0374052018-05-31