| Primary Device ID | 04560189211971 |
| NIH Device Record Key | b3f6c75c-7a4c-4937-ba3f-1165f887bbe0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AIA-PACK PA CALIBRATION VERIFICATION TEST SET |
| Version Model Number | n/a |
| Company DUNS | 690571724 |
| Company Name | TOSOH CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@Tosoh.com | |
| Phone | 650-615-8134 |
| Dave.Wurtz@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 |
| 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 |
| 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 | 04560189211971 [Primary] |
| GS1 | 14560189211978 [Package] Package: [6 Units] In Commercial Distribution |
| JIT | Calibrator, Secondary |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2014-09-24 |