| 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 |