| Device Type ID | 5026 |
| Device Name | Container, Specimen Mailer And Storage, Temperature Controlled, Non-sterile |
| Regulation Description | Specimen Transport And Storage Container. |
| Regulation Medical Specialty | Pathology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.3250 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NNL |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5026 |
| Device | Container, Specimen Mailer And Storage, Temperature Controlled, Non-sterile |
| Product Code | NNL |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Specimen Transport And Storage Container. |
| CFR Regulation Number | 864.3250 [🔎] |
| Device Problems | |
|---|---|
Off-Label Use | 1 |
Inadequate Or Insufficient Training | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 3 |