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 Haematocrit analyser IVD Haematocrit analyser IVD Haematocrit analyser IVD Haematocrit analyser IVD Haematocrit analyser IVD Haematocrit analyser IVD Haematocrit analyser IVD Haematocrit analyser IVD Haematocrit analyser IVD Haematocrit analyser IVD Haematocrit analyser IVD Haematocrit analyser IVD Haematocrit analyser IVD Haematocrit analyser IVD| 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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