| Primary Device ID | 00831829000229 |
| NIH Device Record Key | 82c0b5a1-c7c0-416f-9bf1-5409cbf7e4b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Transparent Disp. Tube Tolders (for HemataSTAT, Cream 50/pkg) |
| Version Model Number | 230-100 |
| Catalog Number | 230-100 |
| Company DUNS | 195501127 |
| Company Name | SEPARATION TECHNOLOGY, INC. |
| Device Count | 50 |
| 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 | 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 |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00831829000229 [Primary] |
| GS1 | 00831829000236 [Unit of Use] |
| GKG | Centrifuge, Hematocrit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-04-18 |
| Device Publish Date | 2017-08-25 |
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| 00831829000410 - HemataSTAT II Centrifuge | 2022-04-08 HemataStat II Microhematocrit System is a small, lightweight centrifuge which provides a rapid and accurate mircohematocrit det |
| 00831829000267 - ClearCRIT® Plastic Capillary Tubes | 2018-08-09 |
| 00831829000281 - ClearCRIT® Plastic Capillary Tubes | 2018-08-09 |
| 00831829000304 - ClearCrit Mylar®Coated Glass Capillary Tubes | 2018-08-09 |
| 00831829000328 - ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes | 2018-08-09 |
| 00831829000403 - ClearCRIT Self-Sealing ®Mylar®Wrapped Capillary Tubes | 2018-08-09 |