| Primary Device ID | 06979259840016 |
| NIH Device Record Key | b97454fb-d61a-491a-b78c-550d76a5cb73 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PEPFAST |
| Version Model Number | PEPF10 |
| Company DUNS | 617582225 |
| Company Name | RD Biomed (Changsha) Limited |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | +8651081819652 |
| pepfast@imaxhealth.com | |
| Phone | +8651081819652 |
| pepfast@imaxhealth.com | |
| Phone | +8651081819652 |
| pepfast@imaxhealth.com | |
| Phone | +8651081819652 |
| pepfast@imaxhealth.com | |
| Phone | +8651081819652 |
| pepfast@imaxhealth.com | |
| Phone | +8651081819652 |
| pepfast@imaxhealth.com | |
| Phone | +8651081819652 |
| pepfast@imaxhealth.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06979259840016 [Primary] |
| JLL | Tubeless Analysis, Gastric Acidity |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-31 |
| Device Publish Date | 2025-12-23 |
| 06979259840023 | Pepfast is a non-invasive in vitro diagnostic test intended for the qualitative detection of pep |
| 06979259840016 | Pepfast is a non-invasive in vitro diagnostic test intended for the qualitative detection of pep |
| 06979259840009 | Pepfast is a non-invasive in vitro diagnostic test intended for the qualitative detection of pep |