WetAlert™ wireless wetness detector
GUDID 00840861101023
WetAlert™ wireless wetness detector
Fresenius Usa, Inc.
Haemodialysis system blood leak detector| Primary Device ID | 00840861101023 |
| NIH Device Record Key | 4c3a170d-90db-437b-b446-c0b9120312fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WetAlert™ wireless wetness detector |
| Version Model Number | 190507 |
| Company DUNS | 076594100 |
| Company Name | Fresenius Usa, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
| Phone | +1(800)227-2572 |
| xxx@xxx.xxx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840861101023 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121421
FDA Product Code
| ONW | Hemodialysis system for home use |
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 | 2015-09-24 |
Devices Manufactured by Fresenius Usa, Inc.
| 00840861102433 - 5008X Hemodialysis Machine | 2024-05-14 5008X with CLiC and BTM |
| 00840861102280 - VersiPD | 2023-08-09 VersiPD Cart |
| 00840861102198 - VersiPD | 2023-02-22 VersiPD Cycler |
| 00840861102297 - VersiPD | 2023-02-22 VersiPD Dialysate Solution Bag Case |
| 00840861100897 - 2008® Series Hemodialysis Machines | 2018-07-06 2008T HEMODIALYSIS SYS., with CDX |
| 00840861100903 - 2008® Series Hemodialysis Machines | 2018-07-06 2008T HEMODIALYSIS SYSTEM WITHOUT CDX |
| 00840861100934 - 2008® Series Hemodialysis Machines | 2018-07-06 2008T HD SYSTEM WITH CDX, CANADA |
| 00840861100941 - 2008® Series Hemodialysis Machines | 2018-07-06 2008K@HOME HEMODIALYSIS SYSTEM |
Trademark Results [WetAlert]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WETALERT 74081505 not registered Dead/Abandoned |
JANJUA, SHAHID I. 1990-07-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.