Hemastix® Reagent Strips 2190
GUDID 00630414550596
HEMASTIX® is a firm plastic strip to which is affixed a reagent area that tests for occult blood in urine. Test results may provide information on urinary tract status.
Siemens Healthcare Diagnostics Inc.
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| NIH Device Record Key | c2d28258-da85-4480-9967-f4430c40bb76 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemastix® Reagent Strips |
| Version Model Number | 10312568 |
| Catalog Number | 2190 |
| Company DUNS | 064608573 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| Device Count | 50 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store in direct sunlight. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414009353 [Unit of Use] |
| GS1 | 00630414550596 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K905396
FDA Product Code
| JIO | BLOOD, OCCULT, COLORIMETRIC, IN URINE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by Siemens Healthcare Diagnostics Inc.
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| 00630414626963 - ADVIA Centaur NT-PBNPII (PBNPII) | 2024-02-13 PBNPII - ADVIA Centaur - MCM Set |
| 00630414626970 - ATELLICA IM NT-PBNPII (PBNPII) | 2024-02-13 PBNPII - ATELLICA IM - MCM Set |
| 00630414284927 - ADVIA Centaur PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 100T |
| 00630414284934 - ADVIA Centaur PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 500T |
| 00630414284941 - Atellica IM PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 100T |
| 00630414284958 - Atellica IM PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 500T |
Trademark Results [Hemastix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMASTIX 97645243 not registered Live/Pending |
Siemens Healthcare Diagnostics Inc. 2022-10-24 |
 HEMASTIX 88167998 not registered Live/Pending |
Ascensia Diabetes Care Holdings AG 2018-10-24 |
 HEMASTIX 72021109 0656285 Live/Registered |
AMES COMPANY, INC. 1956-12-17 |
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