| Primary Device ID | 14560189213392 |
| NIH Device Record Key | 370592ef-d1fc-44ac-a127-6faa76c843ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ST AIA-PACK PROG II |
| Version Model Number | N/A |
| Company DUNS | 690571724 |
| Company Name | TOSOH CORPORATION |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 650-636-8228 |
| Ken.Hood@tosoh.com | |
| Phone | 650-636-8228 |
| Ken.Hood@tosoh.com | |
| Phone | 650-636-8228 |
| Ken.Hood@tosoh.com | |
| Phone | 650-636-8228 |
| Ken.Hood@tosoh.com | |
| Phone | 650-636-8228 |
| Ken.Hood@tosoh.com | |
| Phone | 650-636-8228 |
| Ken.Hood@tosoh.com | |
| Phone | 650-636-8228 |
| Ken.Hood@tosoh.com | |
| Phone | 650-636-8228 |
| Ken.Hood@tosoh.com | |
| Phone | 650-636-8228 |
| Ken.Hood@tosoh.com | |
| Phone | 650-636-8228 |
| Ken.Hood@tosoh.com | |
| Phone | 650-636-8228 |
| Ken.Hood@tosoh.com | |
| Phone | 650-636-8228 |
| Ken.Hood@tosoh.com | |
| Phone | 650-636-8228 |
| Ken.Hood@tosoh.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04560189213395 [Unit of Use] |
| GS1 | 14560189213392 [Primary] |
| NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-22 |
| Device Publish Date | 2019-07-12 |