| Primary Device ID | 00863626000249 |
| NIH Device Record Key | 3de467a7-a182-42a5-891f-0b9335e2f1c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Boekel Large Platelet Incubator |
| Version Model Number | 301650 |
| Company DUNS | 002288215 |
| Company Name | BOEKEL INDUSTRIES, INC. |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 267-989-1143 |
| rrink@boekelsci.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00863626000249 [Primary] |
| KSH | Chamber, Environmental For The Storage Of Platelet Concentrate |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-06-26 |
| Device Publish Date | 2016-09-01 |
| 00863626000270 - Boekel Blood Collection Mixer | 2023-06-16 Device used for the collection of blood combined with a mixing motion. |
| 00863626000294 - Boekel Floor Standing Platelet Incubator Agitator | 2023-06-16 Chamber that maintains 22 degrees C with constant agitation motion for the storage of Platelets. |
| 00863626000218 - Boekel Small Platelet Agitator | 2019-05-24 Device used to agitate platelets. May be used alone if temperature can be maintained to 22 degrees C +/- 2 degrees. may be use |
| 00863626000201 - Boekel Plasma Thawer | 2018-07-06 |
| 00863626000232 - Boekel Small Platelet Incubator | 2018-06-26 |
| 00863626000249 - Boekel Large Platelet Incubator | 2018-06-26 |
| 00863626000249 - Boekel Large Platelet Incubator | 2018-06-26 |
| 00863626000225 - Boekel Large Platelet Agitator | 2018-03-29 Large Platelet Agitator to continuously keep bags of Platelets moving. To be used alone or in conjunction with the Boekel Large |