hollister.comSleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)
Hollister Incorporated
HOLLISTER INCORPORATED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1119193 | 1119193 | HOLLISTER INCORPORATED | 1 | Y | 2026-01-01 | 366 Draft Ave STUARTS DRAFT VA US 24477 |
| 1480288 | 1480288 | HOLLISTER INCORPORATED | 1 | N | 2026-01-01 | 2000 HOLLISTER DR. LIBERTYVILLE IL US 60048 |
| 1921454 | 1921454 | HOLLISTER INCORPORATED | 1 | Y | 2020-04-25 | 1502 E Laharpe St KIRKSVILLE MO US 63501 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00610075040070 | InstaFlo - Bowel Catheter System | +1(800)323-4060 | cs@hollister.com |
| 00610075179626 | ActiFlo - Bowel Catheter System, Drainable Kit | +1(800)323-4060 | cs@hollister.com |
| 00610075179633 | ActiFlo - Bowel Catheter System, Drainable Kit | +1(800)323-4060 | cs@hollister.com |
| 00610075179640 | ActiFlo - Bowel Catheter System, Disposable Kit | +1(800)323-4060 | cs@hollister.com |
| 00610075179657 | ActiFlo - Bowel Catheter System, Disposable Kit | +1(800)323-4060 | cs@hollister.com |
| 10610075180292 | Advance Plus Pocket - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Compact, 10 Fr 16 in, Straight | +1(800)323-4060 | cs@hollister.com |
| 10610075180308 | Advance Plus Pocket - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Compact, 12 Fr 16 in, Straight | +1(800)323-4060 | cs@hollister.com |
| 10610075180315 | Advance Plus Pocket - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Compact, 14 Fr 16 in, Straight | +1(800)323-4060 | cs@hollister.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 2723 | 1798539509 | K992137 | UROLOGICAL CATHETER | GBM | 1999-09-03 |
| 2723 | 1265307125 | K953232 | HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE | KNT | 1995-08-18 |
| 2717 | 1304260181 | K932855 | HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE | KNT | 1993-10-13 |
| 2723 | 1304260181 | K932855 | HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE | KNT | 1993-10-13 |
| 2723 | 1778104110 | K893888 | HOLLISTER FEEDING TUBE ATTACHMENT DEVICE | KNT | 1989-10-17 |
| 2723 | 1309391699 | K862573 | HOLLISTER DRAIN TUBE ATTACHMENT | KNT | 1986-09-23 |
| 2717 | 1309391699 | K862573 | HOLLISTER DRAIN TUBE ATTACHMENT | KNT | 1986-09-23 |
| 2718 | 1371968140 | K781548 | UMBILICAL CORD CLAMP | HFW | 1978-10-17 |
| 2723 | 1326894474 | K253295 | Coude Sleeved IC; Coude Plus Sleeved IC | EZD | 2026-05-18 |
| 2723 | 1496490817 | K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) | EZD | 2024-05-03 |
| 2723 | 1692958276 | K213575 | Female IC (Not Finalized) | EZD | 2022-09-13 |
| 2723 | 1748543798 | K211436 | Intermittent Catheter (Not Finalized) | GBM | 2022-01-27 |
| 2723 | 1415998758 | K193148 | VaPro Plus Pocket, VaPro Plus | GBM | 2019-12-13 |
| 2723 | 1897863551 | K191633 | Infyna Chic | GBM | 2019-07-19 |
| 2723 | 1550197387 | K183253 | ValPro 2 Plus, VaPro 2 Plus Pocket | GBM | 2018-12-18 |
| 2723 | 1358661712 | K180824 | VaPro 2 Intermittent Catheter | GBM | 2018-06-22 |
| 2723 | 1689895899 | K163179 | Onli Intermittent Catheter | GBM | 2017-01-26 |
| 2723 | 1465250946 | K152268 | VAPRO PLUS POCKET Intermittent Catheter | GBM | 2015-09-09 |
| 2723 | 1416404380 | K143594 | VaPro Pocket | GBM | 2015-01-09 |
| 2723 | 1696472706 | K141642 | VAPRO INTERMITTENT CATHETER | GBM | 2014-08-22 |
| 2723 | 1049108172 | K100613 | BIOMED WOUND CLEANSER | FRO | 2011-01-05 |
| 2723 | 1086832626 | K083153 | ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 | KNT | 2009-02-04 |
| 2717 | 1086832626 | K083153 | ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 | KNT | 2009-02-04 |
| 2723 | 1235976920 | K040779 | RESTORE WOUND CLEANSER | KMF | 2004-05-17 |
| 2723 | 1945447266 | K032710 | CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT | KOD | 2004-01-09 |
| 2723 | 1697462494 | K013483 | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT | KOD | 2002-01-14 |
| 2723 | 1741542895 | K013345 | INCARE INTERMITTENT CATHETER | KOD | 2002-01-07 |
| 2723 | 1273702237 | K011552 | UROLOGICAL CATHETER | GBM | 2001-07-18 |
| 2718 | 1016122149 | ||||
| 2718 | 1255222799 | ||||
| 2718 | 1589555073 | ||||
| 2718 | 1602749902 | ||||
| 2718 | 1762329970 | ||||
| 2723 | 1155467556 | ||||
| 2723 | 1155896324 | ||||
| 2717 | 1155896324 | ||||
| 2723 | 1240602801 | ||||
| 2723 | 1254071387 | ||||
| 2723 | 1255222799 | ||||
| 2723 | 1308627748 | ||||
| 2723 | 1432296328 | ||||
| 2723 | 1466145503 | ||||
| 2717 | 1472395612 | ||||
| 2723 | 1472395612 | ||||
| 2717 | 1479694550 | ||||
| 2723 | 1479694550 | ||||
| 2723 | 1504840906 | ||||
| 2723 | 1533217263 | ||||
| 2717 | 1551503658 | ||||
| 2723 | 1551503658 | ||||
| 2717 | 1551675110 | ||||
| 2723 | 1551675110 | ||||
| 2717 | 1650658691 | ||||
| 2723 | 1650658691 | ||||
| 2717 | 1667519951 | ||||
| 2723 | 1667519951 | ||||
| 2717 | 1678222350 | ||||
| 2723 | 1678222350 | ||||
| 2723 | 1762329970 | ||||
| 2717 | 1762329970 | ||||
| 2723 | 1816386135 | ||||
| 2717 | 1835879549 | ||||
| 2723 | 1835879549 | ||||
| 2723 | 1851573452 | ||||
| 2723 | 1886513583 | ||||
| 2723 | 1894042832 | ||||
| 2723 | 2071886547 | ||||
| 2717 | 2071886547 |
Product Codes Associated With Registrations#
PMN#
Sleeved IC
Hollister Incorporated
Female IC (Not Finalized)
Hollister Incorporated
Intermittent Catheter (Not Finalized)
Hollister Incorporated
VaPro Plus Pocket, VaPro Plus
Hollister Incorporated
Infyna Chic
Hollister Incorporated
ValPro 2 Plus, VaPro 2 Plus Pocket
Hollister Incorporated
VaPro 2 Intermittent Catheter
Hollister Incorporated
Onli Intermittent Catheter
HOLLISTER INCORPORATED
VAPRO PLUS POCKET Intermittent Catheter
HOLLISTER INCORPORATED
VaPro Pocket
Hollister Incorporated
GUDID#
InstaFlo - Bowel Catheter System
2016-09-21
ActiFlo - Bowel Catheter System, Drainable Kit
2016-09-21
ActiFlo - Bowel Catheter System, Drainable Kit
2016-09-21
ActiFlo - Bowel Catheter System, Disposable Kit
2016-09-21
ActiFlo - Bowel Catheter System, Disposable Kit
2016-09-21
Advance Plus Pocket - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Compact, 10 Fr 16 in, Straight
2016-09-21
Advance Plus Pocket - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Compact, 12 Fr 16 in, Straight
2016-09-21
Advance Plus Pocket - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Compact, 14 Fr 16 in, Straight
2016-09-21
Advance Plus Pocket - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Compact, 16 Fr 16 in, Straight
2016-09-21
Hollister - Ostomy Irrigation Sleeve
2022-12-01
Hollister - Ostomy Irrigation Sleeve
2022-12-01
VaPro Plus Pocket Kit - No Touch Urethal Intermittent Catheter with Intergrated Collection Bag
2024-07-15
VaPro Plus Pocket Kit - No Touch Urethal Intermittent Catheter with Intergrated Collection Bag
2024-07-15
VaPro Plus Pocket Kit - No Touch Urethal Intermittent Catheter with Intergrated Collection Bag
2024-07-15
VaPro Plus Pocket Kit - No Touch Urethal Intermittent Catheter with Intergrated Collection Bag
2024-07-15
VaPro Plus Pocket Kit - No Touch Urethal Intermittent Catheter with Intergrated Collection Bag
2024-07-15
VaPro Plus Pocket Kit - No Touch Urethal Intermittent Catheter with Intergrated Collection Bag
2025-01-24
VaPro Plus Pocket Kit - No Touch Urethal Intermittent Catheter with Intergrated Collection Bag
2025-01-24
VaPro Plus Pocket Kit - No Touch Urethal Intermittent Catheter with Intergrated Collection Bag
2025-01-24
VaPro Plus Pocket Kit - No Touch Urethal Intermittent Catheter with Intergrated Collection Bag
2025-01-24
VaPro Plus Pocket Kit - No Touch Urethal Intermittent Catheter with Intergrated Collection Bag
2025-01-24
Advance Plus - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 6 Fr 16 in
2016-09-21
Advance Plus - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 8 Fr 16 in
2016-09-21
Advance Plus - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 10 Fr 16 in
2016-09-21
Advance Plus - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 12 Fr 16 in
2016-09-21
Advance Plus - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr 16 in
2016-09-21
Advance Plus - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 16 Fr 16 in
2016-09-21
Advance Plus - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 18 Fr 16 in
2016-09-21
New Image - 2-Piece Ostomy Irrigator Sleeve
2022-12-01
New Image - 2-Piece Ostomy Irrigator Sleeve
2022-12-01
New Image - 2-Piece Ostomy Irrigator Sleeve
2022-12-01
Advance Plus - Closed System Intermittent Catheter Kit, 12 Fr 16 in, Coude
2016-09-21
Advance Plus - Closed System Intermittent Catheter Kit, 16 Fr 16 in, Coude
2016-09-21
Advance Plus - Closed System Intermittent Catheter Kit, 14 Fr 16 in, Coude
2016-09-21
Apogee Plus - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 12 Fr 16 in, Firm, Straight
2016-09-21
Apogee Plus - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 12 Fr 16 in, Soft, Straight
2016-09-21
Apogee Plus - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr 16 in, Firm, Straight
2016-09-21
Apogee Plus - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr 8 in, Female, Firm, Straight
2016-09-21
Apogee Plus - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 14 Fr 16 in, Soft, Straight
2016-09-21
Apogee Plus - Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 16 Fr 16 in, Firm, Straight
2016-09-21