Tasso+
GUDID 10850038691001
The Tasso+ is a single-use blood lancing device intended for obtaining microliter capillary whole blood samples.
Tasso, Inc
Manual blood lancing device, single-use| Primary Device ID | 10850038691001 |
| NIH Device Record Key | 06072da4-7fba-4fa2-b89c-ec3d8e4f58f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tasso+ |
| Version Model Number | K1013-01 |
| Company DUNS | 078431936 |
| Company Name | Tasso, 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 | 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850038691004 [Primary] |
| GS1 | 10850038691001 [Package] Contains: 00850038691004 Package: [60 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221131
FDA Product Code
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10850038691001]
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[10850038691001]
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[10850038691001]
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[10850038691001]
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[10850038691001]
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[10850038691001]
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[10850038691001]
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[10850038691001]
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[10850038691001]
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[10850038691001]
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[10850038691001]
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[10850038691001]
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[10850038691001]
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[10850038691001]
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[10850038691001]
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Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-31 |
| Device Publish Date | 2022-10-21 |
On-Brand Devices [Tasso+]
| 00860006434595 | Tasso+ allows self-collection of a capillary blood sample that is shipped to an accredited labor |
| 10850038691001 | The Tasso+ is a single-use blood lancing device intended for obtaining microliter capillary whol |
Trademark Results [Tasso+]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TASSO+ 90816204 not registered Live/Pending |
TASSO INC. 2021-07-07 |
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