| Primary Device ID | 00812311027610 |
| NIH Device Record Key | 81be9435-c898-450b-871f-399092bc906d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bio Compression Systems Cryo Insert Elbow |
| Version Model Number | CI-3035-E |
| Company DUNS | 101393924 |
| Company Name | Bio Compression Systems, Inc |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00812311027610 [Primary] |
| IRP | Massager, Powered Inflatable Tube |
| JOW | SLEEVE, LIMB, COMPRESSIBLE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2018-10-06 |
| 00812311026255 - BioCryo Sequential Circulator | 2022-04-21 |
| 00812311020062 - 8-Chamber Arm & Shoulder Sleeve - Medium, Left | 2021-09-09 https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml# |
| 00812311020208 - 8-Chamber Arm & Shoulder Sleeve - Medium, Right | 2021-09-09 |
| 00812311021700 - Bio Compression Systems 8 Chamber Leg Sleeve - Large | 2021-09-09 |
| 00812311021717 - Bio Compression Systems 8 Chamber Leg Sleeve - Medium | 2021-09-09 |
| 00812311021724 - Bio Compression Systems 8 Chamber Leg Sleeve - Small | 2021-09-09 |
| 00812311021731 - Bio Compression Systems 4 Chamber Leg Sleeve Large Narrow | 2021-09-09 |
| 00812311021816 - Bio Compression Systems 4 Chamber Leg Sleeve Medium Narrow | 2021-09-09 |