Isofluid™ Earloop Mask w/Secure Fit™ Mask Technology
GUDID 50732224120206
Facemask, Lavender
CROSSTEX INTERNATIONAL, INC.
Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use| Primary Device ID | 50732224120206 |
| NIH Device Record Key | 3bcc6dc8-b0c1-4fb5-bf30-0be023062de7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Isofluid™ Earloop Mask w/Secure Fit™ Mask Technology |
| Version Model Number | GCILVSF |
| Company DUNS | 057728685 |
| Company Name | CROSSTEX INTERNATIONAL, INC. |
| Device Count | 50 |
| 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 | true |
| Expiration Date | false |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00732224120201 [Unit of Use] |
| GS1 | 10732224120208 [Primary] |
| GS1 | 50732224120206 [Package] Contains: 10732224120208 Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K082258
FDA Product Code
| FXX | Mask, 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 | 2022-05-11 |
| Device Publish Date | 2022-05-03 |
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Trademark Results [Isofluid]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISOFLUID 78958015 not registered Dead/Abandoned |
CHEVRON INTELLECTUAL PROPERTY LLC 2006-08-22 |
 ISOFLUID 74612781 1975458 Live/Registered |
CROSSTEX INTERNATIONAL INC. 1994-12-19 |
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