| Primary Device ID | 00816879023114 |
| NIH Device Record Key | e46f04b0-a323-49cd-bc29-d5c5a6d04ce5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NOVEOS Cuvette Arc Pack |
| Version Model Number | 117450-001 |
| Company DUNS | 010558476 |
| Company Name | HYCOR BIOMEDICAL LLC |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816879023114 [Primary] |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-19 |
| Device Publish Date | 2021-01-11 |