Definition: The Device Is Intended To Protect An Insulin Vial Or Vials
| Device Type ID | 2802 |
| Device Name | Insulin Vial Protector/holder |
| Physical State | The Device Is Made Of A Variety Of Durable Plastics And Fabrics. All Devices Consist Of An Inner Core That Surrounds The Vial For Protection. |
| Technical Method | The Device Functions Independently Providing A Protective Barrier To Shield And Protect The Insulin Vial. |
| Target Area | The Device Is Intended To Protect The Insulin Vial. The Device Itself Does Not Act On The Body At All. |
| Regulation Description | Daily Activity Assist Device. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 890.5050 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OJL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2802 |
| Device | Insulin Vial Protector/holder |
| Product Code | OJL |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Daily Activity Assist Device. |
| CFR Regulation Number | 890.5050 [🔎] |