Resistex
GUDID 10641043370001
MERCURY ENTERPRISES, INC.
Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer Incentive spirometer| Primary Device ID | 10641043370001 |
| NIH Device Record Key | 72b17b66-2e7b-484e-9312-c321163f2fe3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Resistex |
| Version Model Number | 10-37000 |
| Company DUNS | 032705659 |
| Company Name | MERCURY ENTERPRISES, 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10641043370001 [Primary] |
| GS1 | 30641043370005 [Package] Package: [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K942919
FDA Product Code
| BWF | Spirometer, Therapeutic (Incentive) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-04-09 |
| Device Publish Date | 2016-03-02 |
On-Brand Devices [Resistex]
| 30641043370012 | 10-37001 |
| 10641043370001 | 10-37000 |
Trademark Results [Resistex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESISTEX 90138799 not registered Live/Pending |
U.S. Glove Co., Inc. 2020-08-26 |
 RESISTEX 85609160 4407926 Live/Registered |
AMCOL International Corporation 2012-04-26 |
 RESISTEX 77106039 not registered Dead/Abandoned |
Sage Products, Inc. 2007-02-13 |
 RESISTEX 75692962 2340990 Live/Registered |
PLANTIVA LLC 1999-04-26 |
 RESISTEX 75310346 not registered Dead/Abandoned |
Botanica Laboratories International, Inc. 1997-06-17 |
 RESISTEX 74466868 1864608 Live/Registered |
MERCURY ENTERPRISES, INC. 1993-12-06 |
 RESISTEX 74075345 1659770 Dead/Cancelled |
Parex, Incorporated 1990-07-05 |
 RESISTEX 74071815 1642850 Dead/Cancelled |
American Manufacturing Company, Inc. 1990-06-22 |
 RESISTEX 72097361 0751506 Dead/Expired |
AMERICAN MANUFACTURING COMPANY, INC. 1960-05-18 |
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