| Primary Device ID | 60888937027206 |
| NIH Device Record Key | f56a5457-f8aa-4b9a-b9c5-ca8caabe4fa6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ERPeak |
| Version Model Number | ER20190829-05 |
| Company DUNS | 801895244 |
| Company Name | Coopersurgical, 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 | true |
| 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 | 60888937027206 [Primary] |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-18 |
| Device Publish Date | 2024-04-10 |
| 60888937027206 | IVD Sample kit |
| 60888937027190 | IVD Sample kit |
| 60888937027183 | IVD Sample kit |
| 60888937027176 | IVD Sample kit |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ERPEAK 88109017 5864194 Live/Registered |
CooperSurgical, Inc. 2018-09-07 |