| Primary Device ID | 00817827027543 |
| NIH Device Record Key | a39addc5-67d2-4d7d-a982-72065dec41f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXP-PAK |
| Version Model Number | EXP-500 |
| Catalog Number | EXP-500 |
| Company DUNS | 029062325 |
| Company Name | CHARTER MEDICAL, LTD. |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 866-458-3116 |
| CML_customerservice@chartermedical.com | |
| Phone | 866-458-3116 |
| CML_customerservice@chartermedical.com | |
| Phone | 866-458-3116 |
| CML_customerservice@chartermedical.com | |
| Phone | 866-458-3116 |
| CML_customerservice@chartermedical.com | |
| Phone | 866-458-3116 |
| CML_customerservice@chartermedical.com | |
| Phone | 866-458-3116 |
| CML_customerservice@chartermedical.com | |
| Phone | 866-458-3116 |
| CML_customerservice@chartermedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817827027048 [Primary] |
| GS1 | 00817827027543 [Package] Contains: 00817827027048 Package: [12 Units] In Commercial Distribution |
| KJF | System, Suspension, Cell Culture |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-31 |
| Device Publish Date | 2021-08-23 |
| 00817827027550 | EXP-Pak Cell Expansion Container 50 mL Capacity |
| 00817827027543 | EXP-PAK Cell Expansion Container 500 mL Capacity |
| 00817827027536 | EXK-Pak Cell Expansion Container 5L Capacity |
| 00817827027529 | EXP-Pak Cell Expansion Container 3L Capacity |
| 00817827027512 | EXP-PAK Cell Expansion Container 1L Capacity |