UltraCrit 100-200
GUDID 00831829000014
UltraCrit Hematocrit measurement device (UltraCrit) employs ultrasound technology to accurately measure hematocrit (Hct) in whole blood. For In-Vitro diagnostics use.
SEPARATION TECHNOLOGY, INC.
Haematocrit analyser IVD, automated| Primary Device ID | 00831829000014 |
| NIH Device Record Key | dd64b948-dea6-4091-b969-f313d87a835e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UltraCrit |
| Version Model Number | 100-200 |
| Catalog Number | 100-200 |
| Company DUNS | 195501127 |
| Company Name | SEPARATION TECHNOLOGY, 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 | 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 |
Customer Support Contacts
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00831829000014 [Primary] |
FDA Product Code
| GKF | Instrument, Hematocrit, Automated |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-08-25 |
Devices Manufactured by SEPARATION TECHNOLOGY, INC.
| 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 |
Trademark Results [UltraCrit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULTRACRIT 76512229 3245249 Live/Registered |
Separation Technology, Inc. 2003-05-07 |
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