| Primary Device ID | 04719875918100 |
| NIH Device Record Key | a7c32e6a-a4ca-4922-a8a5-f1609345e1fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Transcend Blood Collection Tube Holder |
| Version Model Number | B00080002 |
| Company DUNS | 656153288 |
| Company Name | AEON BIOTHERAPEUTICS CORP. |
| 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 | true |
| Expiration Date | false |
| 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 | 04719875918100 [Primary] |
| GS1 | 14719875918107 [Package] Package: carton [250 Units] In Commercial Distribution |
| GS1 | 94719875918103 [Package] Package: carton [100 Units] In Commercial Distribution |
| KST | System, Blood Collection, Vacuum-Assisted, Manual |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-15 |
| Device Publish Date | 2025-08-07 |
| 04719875918087 - Disc Filter | 2025-08-21 |
| 14719875912242 - Transcend PRP | 2025-08-15 |
| 14719875912259 - Transcend PRP | 2025-08-15 |
| 04719875918100 - Transcend Blood Collection Tube Holder | 2025-08-15 |
| 04719875918100 - Transcend Blood Collection Tube Holder | 2025-08-15 |
| 04719875912122 - Virtue CPKit | 2025-05-23 |
| 04719875912139 - Virtue CPKit | 2025-05-23 |
| 04719875912146 - Virtue CPKit | 2025-05-23 |
| 04719875912153 - Virtue CPKit | 2025-05-23 |