| Primary Device ID | 10819374024966 | 
| NIH Device Record Key | f06377b7-380e-40ec-924d-488a3d8c6d7c | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | allFlex | 
| Version Model Number | allFlex Ureteral Catheter Angle Open Tip 3F, 70cm | 
| Catalog Number | UC-AO3 | 
| Company DUNS | 796354509 | 
| Company Name | ALLWIN MEDICAL DEVICES, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | |
| Phone | 714-572-1709 | 
| info@allwinmedical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00819374024969 [Primary] | 
| GS1 | 10819374024966 [Package] Contains: 00819374024969 Package: Box Packing [10 Units] In Commercial Distribution | 
| KOD | Catheter, Urological | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-08-09 | 
| Device Publish Date | 2023-08-01 | 
| 00812261016597 - ASPI | 2024-02-16 ASPI Aspiration Needle 22G,30cm | 
| 10819374020401 - Krait | 2023-08-09 Krait Ureteral Catheter Open Tip 4F, 70cm | 
| 10819374020418 - Krait | 2023-08-09 Krait Ureteral Catheter Open Tip 3F, 70cm | 
| 10819374022382 - Krait | 2023-08-09 Krait Ureteral Catheter Closed Tip 3F, 70cm | 
| 10819374022399 - Krait | 2023-08-09 Krait Ureteral Catheter Closed Tip 4F, 70cm | 
| 10819374022405 - Krait | 2023-08-09 Krait Ureteral Catheter Closed Tip 5F, 70cm | 
| 10819374023174 - Krait | 2023-08-09 Krait Ureteral Catheter Closed Tip 6F, 70cm | 
| 10819374024379 - Krait | 2023-08-09 Krait Ureteral Catheter Open Tip 7F, 70cm | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ALLFLEX  85570522  4210074 Dead/Cancelled | Nitron International LLC 2012-03-15 | 
|  ALLFLEX  79137880  not registered Dead/Abandoned | Franc SITAR 2013-08-28 | 
|  ALLFLEX  77720690  3711872 Live/Registered | ALLMAX NUTRITION INC. 2009-04-23 | 
|  ALLFLEX  76701406  3836451 Live/Registered | ALLOY FASTENERS, INC 2010-01-29 | 
|  ALLFLEX  76372595  2755294 Live/Registered | ALLFLEX USA, INC. 2002-02-20 | 
|  ALLFLEX  76372594  2731475 Live/Registered | ALLFLEX USA, INC. 2002-02-20 | 
|  ALLFLEX  76372593  2755293 Live/Registered | ALLFLEX USA, INC. 2002-02-20 | 
|  ALLFLEX  76372495  2755290 Live/Registered | ALLFLEX USA, INC. 2002-02-20 | 
|  ALLFLEX  76368338  2746289 Live/Registered | Allflex USA, Inc. 2002-02-08 | 
|  ALLFLEX  76368337  2829104 Live/Registered | ALLFLEX USA, INC. 2002-02-08 | 
|  ALLFLEX  76366113  not registered Dead/Abandoned | ALLFLEX USA, INC. 2002-02-04 | 
|  ALLFLEX  76366112  not registered Dead/Abandoned | Allflex USA, Inc. 2002-02-04 |