Thoraguard TGDK110012
GUDID 10860000436417
Thoraguard Drainage Kit
CENTESE, INC.
Surgical suction system collection container, single-use| Primary Device ID | 10860000436417 |
| NIH Device Record Key | 7fe52e6f-3703-4f88-af79-e4055635de2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thoraguard |
| Version Model Number | FGS-1125 |
| Catalog Number | TGDK110012 |
| Company DUNS | 081331672 |
| Company Name | CENTESE, 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 | 00860000436410 [Primary] |
| GS1 | 10860000436417 [Package] Contains: 00860000436410 Package: Box [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181667
FDA Product Code
| BTA | Pump, Portable, Aspiration (Manual Or Powered) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-15 |
| Device Publish Date | 2020-10-07 |
On-Brand Devices [Thoraguard]
| 10860000436424 | Thoraguard Control Module |
| 10860000436417 | Thoraguard Drainage Kit |
| 10860000436400 | Thoraguard Chest Tube Kit, 20 Fr |
| 00860000436441 | Thoraguard Chest Tube Kit, 28 Fr |
Trademark Results [Thoraguard]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THORAGUARD 87905044 not registered Live/Pending |
CENTESE, INC. 2018-05-02 |
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