Crosstex™ Isolator™ Molded N95 Surgical Respirator
GUDID 50732224004698
Surgical Respirator
CROSSTEX INTERNATIONAL, INC.
Surgical/medical respirator, non-antimicrobial, single-use| Primary Device ID | 50732224004698 |
| NIH Device Record Key | d5eb3973-1cdf-4ced-9dd9-3c3c25c4553a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Crosstex™ Isolator™ Molded N95 Surgical Respirator |
| Version Model Number | GMLN95 |
| Company DUNS | 057728685 |
| Company Name | CROSSTEX INTERNATIONAL, INC. |
| Device Count | 20 |
| DM Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(888)276-7783 |
| crosstex@crosstex.com | |
| Phone | +1(888)276-7783 |
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| Phone | +1(888)276-7783 |
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| Phone | +1(888)276-7783 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00732224004693 [Unit of Use] |
| GS1 | 10732224004690 [Primary] |
| GS1 | 50732224004698 [Package] Contains: 10732224004690 Package: Case [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061375
FDA Product Code
| MSH | Respirator, surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-22 |
| Device Publish Date | 2021-06-14 |
Devices Manufactured by CROSSTEX INTERNATIONAL, INC.
| 10732224000050 - Crosstex International | 2025-07-25 (POUCH 5.25X10 SELFSEAL) |
| 30732224120233 - Isofluid Surgical Masks | 2025-07-15 With Fog Free Strip and Shield. ASTM Level 1, Blue |
| 50732224005008 - Safe-Flo Plus Saliva Ejector | 2024-12-02 White/White |
| 50732224004988 - Safe-Flo Plus Saliva Ejector | 2024-12-02 Clear/White |
| 50732224005015 - Safe-Flo Plus Saliva Ejector | 2024-12-02 White/Green, Mint Scented |
| 50732224005022 - Safe-Flo Plus Saliva Ejector | 2024-12-02 White/Pink, Bubblegum Scented |
| 00732224005508 - DentaPure 365-Day Independent Water Bottle Cartridge | 2024-09-16 Water Purification Bottle Cartridge |
| 00732224005515 - DentaPure Water Purification Municipal Cartridge | 2024-09-16 Water Purification Municipal Cartridge |
Trademark Results [Crosstex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CROSSTEX 78524596 3038011 Dead/Cancelled |
Crosstex Energy Services, L.P. 2004-11-30 |
 CROSSTEX 77230322 3514876 Live/Registered |
Crosstex International, Inc. 2007-07-16 |
 CROSSTEX 73645498 1458201 Live/Registered |
CROSS COUNTRY PAPER PRODUCTS CORP. 1987-02-19 |
 CROSSTEX 73278430 1184902 Dead/Cancelled |
Crosstex, Inc. 1980-09-19 |
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