Flexitouch Plus
GUDID 00816305023541
TACTILE SYSTEMS TECHNOLOGY, INC.
Multi-chamber venous compression system garment, reusable| Primary Device ID | 00816305023541 |
| NIH Device Record Key | e4130dc9-f4e1-428d-b4d2-d5feb25812c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Flexitouch Plus |
| Version Model Number | 300007-000-00 |
| Company DUNS | 146295980 |
| Company Name | TACTILE SYSTEMS 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816305023541 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170216
FDA Product Code
| PPS | Sleeve, Head And Neck, Compressible |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-02-15 |
On-Brand Devices [Flexitouch Plus]
Trademark Results [Flexitouch Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLEXITOUCH PLUS 88060880 5877526 Live/Registered |
Tactile Systems Technology, Inc. 2018-08-01 |
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