| Primary Device ID | 00815849023406 |
| NIH Device Record Key | b0854b51-824c-4fc3-b62f-cf1142a8d6c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PG-1000 |
| Version Model Number | PG-1000 |
| Company DUNS | 948904735 |
| Company Name | CUSTOM ASSEMBLIES, 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815849023406 [Primary] |
| FPA | Set, Administration, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-21 |
| Device Publish Date | 2023-09-13 |
| 00815849024021 - Custom Medical Specialties, Inc. | 2023-09-22 Procedure Kit |
| 00815849024571 - Custom Medical Specialties, Inc. | 2023-09-22 Procedure Kit |
| 00815849023369 - Custom Medical Specialties, Inc. | 2023-09-21 8’ Extension Set with Check Valve |
| 00815849023390 - Custom Medical Specialties, Inc. | 2023-09-21 144" Transition Tubing |
| 00815849023406 - PG-1000 | 2023-09-21Puregraft Smart Tubing |
| 00815849023406 - PG-1000 | 2023-09-21 Puregraft Smart Tubing |
| 00815849023437 - Custom Assemblies, Inc. | 2023-09-21 Procedure Kit |
| 00815849023444 - Custom Assemblies, Inc. | 2023-09-21 Procedure Kit |
| 00815849023451 - Custom Medical Specialties, Inc. | 2023-09-21 Procedure Kit |