| Primary Device ID | 10817640021343 |
| NIH Device Record Key | 68756871-6df3-4c54-98b5-dd9055f416ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ulti-Flo General Purpose Drainage Catheter |
| Version Model Number | LBL2-1630HB |
| Catalog Number | LBL2-1630HB |
| Company DUNS | 192559557 |
| Company Name | URESIL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com | |
| Phone | 1-800-538-7374 |
| sales@uresil.com |
| Catheter Gauge | 16 French |
| Length | 20 Centimeter |
| Catheter Gauge | 16 French |
| Length | 20 Centimeter |
| Catheter Gauge | 16 French |
| Length | 20 Centimeter |
| Catheter Gauge | 16 French |
| Length | 20 Centimeter |
| Catheter Gauge | 16 French |
| Length | 20 Centimeter |
| Catheter Gauge | 16 French |
| Length | 20 Centimeter |
| Catheter Gauge | 16 French |
| Length | 20 Centimeter |
| Catheter Gauge | 16 French |
| Length | 20 Centimeter |
| Catheter Gauge | 16 French |
| Length | 20 Centimeter |
| Catheter Gauge | 16 French |
| Length | 20 Centimeter |
| Catheter Gauge | 16 French |
| Length | 20 Centimeter |
| Catheter Gauge | 16 French |
| Length | 20 Centimeter |
| Catheter Gauge | 16 French |
| Length | 20 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817640021346 [Primary] |
| GS1 | 10817640021343 [Package] Contains: 00817640021346 Package: Dispenser [5 Units] In Commercial Distribution |
| GS1 | 20817640021340 [Package] Package: Shipper [4 Units] In Commercial Distribution |
| HIBCC | H862LBL21630HB0 [Previous] |
| GBO | Catheter, Nephrostomy, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-06 |
| Device Publish Date | 2022-04-28 |
| H862LBNL2850H2 | HYDROPHILIC COATED LARGE BORE NON-LOCKING CATHETER, 28F |
| H862LBNL2450H2 | HYDROPHILIC COATED LARGE BORE NON-LOCKING CATHETER, 24F |
| H862LBNL2050H2 | HYDROPHILIC COATED LARGE BORE NON-LOCKING CATHETER, 20F |
| H862LBL21630HB2 | HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 16F |
| H862LBL21430HB2 | HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 14F |
| H862LBL2T1630HB1 | HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 16F |
| H862LBL2T1430HB1 | HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 14F |
| 10817640020490 | HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 16F |
| 10817640020483 | HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 14F |
| 10817640021343 | HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 16F |
| 10817640021336 | HYDROPHILIC COATED LARGE BORE LOCKING CATHETER WITH DEPTH MARKS, 14F |