| Primary Device ID | 00840682138925 | 
| NIH Device Record Key | 9e1239b6-37c4-4c29-883c-dd67d03d867d | 
| Commercial Distribution Status | In Commercial Distribution | 
| Version Model Number | B2100BLT | 
| Company DUNS | 654659689 | 
| Company Name | Hangwei GE Medical Systems Co., Ltd. | 
| 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 | false | 
| Lot Batch | false | 
| Serial Number | true | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00840682138925 [Primary] | 
| CCX | SUPPORT, PATIENT POSITION | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2018-12-14 | 
| Device Publish Date | 2018-11-13 | 
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