| Primary Device ID | 00831829000458 |
| NIH Device Record Key | 479fce3a-607f-4a1e-84de-0beb323cee7e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg) |
| Version Model Number | 230-100D |
| Catalog Number | 230-100D |
| 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 | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com | |
| Phone | 1800-531-5535 |
| info@ekfdiagnostics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00831829000441 [Primary] |
| GS1 | 00831829000458 [Unit of Use] |
| GKG | Centrifuge, Hematocrit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-14 |
| Device Publish Date | 2023-11-06 |
| 00831829000458 - 3D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg) | 2023-11-14 |
| 00831829000458 - 3D Printed Disp. Tube Holders (for HemataSTAT, Cream 50/pkg) | 2023-11-14 |
| 00831829000427 - UltraCrit Loaner | 2023-03-09 UltraCrit Hematocrit measurement device (UltraCrit) employs ultrasound technology to accurately measure hematocrit (Hct) in whol |
| 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 |