| Primary Device ID | H862PDC362 |
| NIH Device Record Key | a9338d46-2774-4e42-af08-4bbc5b388e51 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gravity Drainage Bag |
| Version Model Number | PDC-36 |
| Catalog Number | PDC-36 |
| 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 | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM | |
| Phone | 1-800-538-7374 |
| SALES@URESIL.COM |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Length | 36 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H862PDC360 [Primary] |
| HIBCC | H862PDC362 [Package] Contains: H862PDC360 Package: SHIPPER [75 Units] In Commercial Distribution |
| EXF | Bag, Bile Collecting |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-09-11 |
| H862TC600L2 | Optimus 600 Gravity Drainage Bag w/36" I.T. |
| H862TC6002 | Optimus 600 Gravity Drainage Bag w/20" I.T. |
| H862PDC362 | Percutaneous Drainage Catheter Connector Tubing |
| 10817640020568 | Optimus 600 Gravity Drainage Bag w/36" I.T. |
| 10817640020551 | Optimus 600 Gravity Drainage Bag w/20" I.T. |