FDA.reportPublic FDA data

Haemodialysis/central venous catheterization kit

Definition
A collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access during haemodialysis, by: 1) conducting blood from a patient and returning it after extracorporeal circulation, primarily during haemodialysis, but may also be intended for haemoperfusion and/or apheresis; and 2) enabling central venous access for intravenous (IV) administration and/or invasive venous blood pressure monitoring. It includes a nonimplantable triple-lumen haemodialysis catheter, devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.
GUDID devices
97
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00819667020241MEDADVMEDAS INCM2162018-04-09
00849884003154VYGONVygon CorporationAMS-8186CP2020-03-27
06938634454309Disposable Hemodialysis Access Catheter Set Guangdong Baihe Medical Technology Co., Ltd.Single Lumen8F*10cm2016-09-22
06938634454422Disposable Hemodialysis Access Catheter Set Guangdong Baihe Medical Technology Co., Ltd.Single Lumen7F*10cm2016-09-22
06938634496408Disposable Hemodialysis Access Catheter Set Guangdong Baihe Medical Technology Co., Ltd.Double Lumen14F*24cm2016-09-22
08498840002186VYGONVygon CorporationAMS-7328SF2016-08-11
08498840002483VYGONVygon CorporationAMS-8018CP2016-08-11
08498840002551VYGONVygon CorporationAMS-8059CP2016-08-11
08498840002926VYGONVygon CorporationAMS-8186CP2016-09-07
10801902111699ARROWTELEFLEX INCORPORATEDIPN0361792015-11-20
10801902111705ARROWTELEFLEX INCORPORATEDIPN0361802015-11-20
10801902111712ARROWTELEFLEX INCORPORATEDIPN0361812015-11-20
10801902111729ARROWTELEFLEX INCORPORATEDIPN0361822015-11-20
10801902111736ARROWTELEFLEX INCORPORATEDIPN0361832015-11-20
10801902111743ARROWTELEFLEX INCORPORATEDIPN0361842015-11-20
10801902111750ARROWTELEFLEX INCORPORATEDIPN0361852015-11-20
10801902111767ARROWTELEFLEX INCORPORATEDIPN0361862015-11-20
10801902111774ARROWTELEFLEX INCORPORATEDIPN0361872015-11-20
10801902111781ARROWTELEFLEX INCORPORATEDIPN0361882015-11-20
10801902111798ARROWTELEFLEX INCORPORATEDIPN0361892015-12-03
10801902111804ARROWTELEFLEX INCORPORATEDIPN0361902015-11-20
10801902111811ARROWTELEFLEX INCORPORATEDIPN0361912015-12-03
10801902111828ARROWTELEFLEX INCORPORATEDIPN0361922015-11-20
10801902111835ARROWTELEFLEX INCORPORATEDIPN0361932015-12-03
10801902111842ARROWTELEFLEX INCORPORATEDIPN0361942015-12-03
10801902111859ARROWTELEFLEX INCORPORATEDIPN0361952015-11-20
10801902111866ARROWTELEFLEX INCORPORATEDIPN0361962015-11-20
10801902129526ARROWTELEFLEX INCORPORATEDIPN0375932016-11-11
10801902129540ARROWTELEFLEX INCORPORATEDIPN0375942016-09-30
10801902129564ARROWTELEFLEX INCORPORATEDIPN0375952016-09-30
10801902131635ARROWTELEFLEX INCORPORATEDIPN9118252017-02-14
10801902131642ARROWTELEFLEX INCORPORATEDIPN9118302017-02-14
10801902143133ARROWTELEFLEX INCORPORATEDIPN0386442018-09-04
10801902186338ARROWTELEFLEX INCORPORATEDIPN9193422021-12-29
10801902186369ARROWTELEFLEX INCORPORATEDIPN9193452021-12-29
10801902186499ARROWTELEFLEX INCORPORATEDIPN9193582022-01-05
10801902202434ARROWTELEFLEX INCORPORATEDIPN9226712024-09-06
10801902202441ARROWTELEFLEX INCORPORATEDIPN9226722024-09-06
10801902213409ARROWTELEFLEX INCORPORATEDIPN9273322023-04-20
10801902213416ARROWTELEFLEX INCORPORATEDIPN9273332023-04-20
10801902213423ARROWTELEFLEX INCORPORATEDIPN9273342023-04-20
10801902213447ARROWTELEFLEX INCORPORATEDIPN9273362023-04-19
10801902213454ARROWTELEFLEX INCORPORATEDIPN9273372023-04-19
10801902222456ARROWTELEFLEX INCORPORATEDIPN9307092025-04-03
10801902222463ARROWTELEFLEX INCORPORATEDIPN9307102025-04-03
30801902111716ARROWTELEFLEX INCORPORATEDIPN0361812018-02-02
30801902111747ARROWTELEFLEX INCORPORATEDIPN0361842018-12-11
30801902111754ARROWTELEFLEX INCORPORATEDIPN0361852018-03-07
30801902111785ARROWTELEFLEX INCORPORATEDIPN0361882017-05-03
30801902111815ARROWTELEFLEX INCORPORATEDIPN0361912017-05-03
30801902111822ARROWTELEFLEX INCORPORATEDIPN0361922017-05-03
30801902111846ARROWTELEFLEX INCORPORATEDIPN0361942018-03-07
40801902111690ARROWTELEFLEX INCORPORATEDIPN0361792018-12-11
40801902111706ARROWTELEFLEX INCORPORATEDIPN0361802018-12-11
40801902111737ARROWTELEFLEX INCORPORATEDIPN0361832018-12-11
40801902111768ARROWTELEFLEX INCORPORATEDIPN0361862018-03-07
40801902111799ARROWTELEFLEX INCORPORATEDIPN0361892018-03-07
40801902111805ARROWTELEFLEX INCORPORATEDIPN0361902018-03-07
40801902111867ARROWTELEFLEX INCORPORATEDIPN0361962017-07-14
50801902111772ARROWTELEFLEX INCORPORATEDIPN0361872017-05-03
50801902111833ARROWTELEFLEX INCORPORATEDIPN0361932018-03-07
20801902222453ARROWTELEFLEX INCORPORATEDIPN9307092025-04-03
20801902222460ARROWTELEFLEX INCORPORATEDIPN9307102025-04-03
20801902202431ARROWTELEFLEX INCORPORATEDIPN9226712024-09-06
20801902202448ARROWTELEFLEX INCORPORATEDIPN9226722024-09-06
26938634454303Disposable Hemodialysis Access Catheter Set Guangdong Baihe Medical Technology Co., Ltd.Single Lumen8F*10cm2016-09-22
26938634454426Disposable Hemodialysis Access Catheter Set Guangdong Baihe Medical Technology Co., Ltd.Single Lumen7F*10cm2016-09-22
06938634469822Disposable Hemodialysis Access Catheter Set Guangdong Baihe Medical Technology Co., Ltd.Double Lumen12F*20cm2016-09-20
06938634469907Disposable Hemodialysis Access Catheter Set Guangdong Baihe Medical Technology Co., Ltd.Double Lumen12F*16cm2016-09-20
20801902186496ARROWTELEFLEX INCORPORATEDIPN9193582022-01-05
20801902213406ARROWTELEFLEX INCORPORATEDIPN9273322023-04-20
20801902213413ARROWTELEFLEX INCORPORATEDIPN9273332023-04-20
20801902213420ARROWTELEFLEX INCORPORATEDIPN9273342023-04-20
20801902213444ARROWTELEFLEX INCORPORATEDIPN9273362023-04-19
20801902213451ARROWTELEFLEX INCORPORATEDIPN9273372023-04-19
20801902186335ARROWTELEFLEX INCORPORATEDIPN9193422021-12-29
20801902186366ARROWTELEFLEX INCORPORATEDIPN9193452021-12-29
20801902143130ARROWTELEFLEX INCORPORATEDIPN0386442018-09-04
30849884003155VYGONVygon CorporationAMS-8186CP2020-03-27
40801902111713ARROWTELEFLEX INCORPORATEDIPN0361812018-02-02