| Primary Device ID | 20889483227272 |
| NIH Device Record Key | c222a1d2-d337-4603-9d56-7b120acdffd6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BiFLo™ |
| Version Model Number | 0106 |
| Catalog Number | 0106 |
| Company DUNS | 069009268 |
| Company Name | SUNMED, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00709078003714 [Previous] |
| GS1 | 10889483227275 [Primary] |
| GS1 | 20889483227272 [Package] Contains: 10889483227275 Package: Box [25 Units] In Commercial Distribution |
| BYG | Mask, Oxygen |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-07 |
| Device Publish Date | 2025-12-30 |
| 20889483227272 | BiFLo™ Mask |
| 20889483227265 | BiFLo™ Mask \ |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIFLO 78844696 not registered Dead/Abandoned |
Critical Therapeutics, Inc. 2006-03-23 |
![]() BIFLO 75588511 not registered Dead/Abandoned |
Glaxo Wellcome Inc. 1998-11-13 |
![]() BIFLO 75359653 not registered Dead/Abandoned |
Glaxo Wellcome Inc. 1997-09-19 |