| Primary Device ID | 00815849020108 |
| NIH Device Record Key | 229126c3-fc7e-4209-aa9a-ef766be0dc19 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Custom Medical Specialties, Inc. |
| Version Model Number | CMS-1637 |
| Company DUNS | 948904735 |
| Company Name | CUSTOM ASSEMBLIES, INC. |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815849020108 [Primary] |
| GS1 | 00815849020566 [Package] Package: [25 Units] In Commercial Distribution |
| FMH | Container, Specimen, 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 | 2016-11-21 |
| 00815849023222 | 62" Straight Injection Line - Sterile |
| 00815849023192 | Custom Tubing Set w/ Multi-Step Connector - Sterile |
| 00815849023178 | 36" x 36" Bandbag - Sterile |
| 00815849023130 | Catheter Adapter - Sterile |
| 00815849023123 | 3" IV Transfer Connecting Set - Sterile |
| 00815849023109 | 5" x 12" Band Bag - Non-Sterile |
| 00815849023093 | Instillation (BCG) Kit - Sterile |
| 00815849023062 | US Probe Cover, Rolled 5" x 93" - Sterile |
| 00815849023031 | Short Expandable Hose - Non-Sterile |
| 00815849023017 | Urological Drainbag w/ 6mm Plug for Skytron Systems- Sterile |
| 00815849022997 | Custom Tubing 48" Extension Set - Sterile |
| 00815849022973 | Custom Tumescent Set - Non-Sterile |
| 00815849022935 | Urology Tubing Set - Sterile |
| 00815849022874 | Halstead Mosquito Forcep - Sterile |
| 00815849022850 | Universal Urological Drainbag w/ 12"x12" 2ml Vented Polybag - Non-Sterile |
| 00815849022737 | Universal Urological Drainage Bag w/ XL Hose - Non-Sterile |
| 00815849022713 | Polyvinyl Urological Drainage Bag for Skytron Systems - Non-Sterile |
| 00815849022690 | Vinyl Acetate Urological Drainage Bag for Dornier Systems - Non-Sterile |
| 00815849022676 | Vinyl Acetate Urological Drainage Bag for Skytron Systems w/ 8mm Plug - Non-Sterile |
| 00815849022652 | Polyvinyl Urological Drainage Bag for Skytron Systems w/ 10mm Plug - Non-Sterile |
| 00815849022638 | Vinyl Acetate Urological Drainage Bag for GE/OEC Systems w/ 8mm Plug - Non-Sterile |
| 00815849022614 | Polyvinyl Urological Drainage Bag for GE/OEC Systems w/ 10mm Plug - Non-Sterile |
| 00815849022591 | Vinyl Acetate Urological Drainage Bag for Liebel/OEC Systems w/ 6mm Plug - Non-Sterile |
| 00815849022577 | Vinyl Acetate Urological Drainage Bag for Siemens Systems w/ 6mm Plug - Non-Sterile |
| 00815849022553 | Polyvinyl Urological Drainage Bag for Siemens Systems w/ XL Hose - Non-Sterile |
| 00815849022539 | Polyvinyl Urological Drainage Bag for Siemens Systems w/ 6mm Plug - Non-Sterile |
| 00815849022515 | Polyvinyl Urological Drainage Bag for Siemens Systems w/ 10mm Plug - Non-Sterile |
| 00815849022492 | 72" Drainbag Hose - Non-Sterile |
| 00815849022478 | Collection Bag Y-Connector - Non-Sterile |
| 00815849022454 | Large Suction Tubing - Sterile |
| 00815849022430 | Universal Urological Drainage Bag w/ 8mm Plug - Sterile |
| 00815849022416 | Universal Urological Drainage Bag w/ 6mm Plug - Sterile |
| 00815849022393 | Vinyl Acetate Urological Drainage Bag for Skytron Systems w/ 8mm Plug - Sterile |
| 00815849022379 | Vinyl Acetate Urological Drainage Bag for Skytron Systems - Sterile |
| 00815849022355 | Polyvinyl Urological Drainage Bag for Skytron Systems w/ 6mm Plug - Sterile |
| 00815849022331 | Polyvinyl Urological Drainage Bag for Skytron Systems - Sterile |
| 10815849022314 | Polyvinyl Urological Drainage Bag for GE/OEC Systems - Sterile |
| 00815849022300 | Vinyl Acetate Urological Drainage Bag for Liebel Systems - Sterile |
| 00815849022287 | Vinyl Acetate Urological Drainage Bag for Siemens Systems - Sterile |
| 00815849022263 | Polyvinyl Urological Drainage Bag for Siemens Systems - Sterile |
| 00815849022249 | 36" Console Cover - Sterile |
| 00815849022225 | 86" x 135" Femoral Drape - Sterile |
| 00815849022201 | Procedure Drape - Sterile |
| 00815849022188 | 6" x 96" Probe Cover w/ Bands and Gel - Sterile |
| 00815849022164 | 86" x 125" Femoral Drape - Sterile |
| 00815849022140 | Fan Folded Table Cover - Sterile |
| 00815849022126 | Foam Prep Sticks - Sterile |
| 00815849022102 | Towel Clamp - Non-Sterile |
| 00815849022089 | Custom HSG Catheter - Sterile |
| 00815849022065 | Angled Prep Stick - Non-Sterile |