| Primary Device ID | 00850022550218 |
| NIH Device Record Key | 431c8ce0-6cec-4842-adbc-81096787e76b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fold Flat Surgical Mask |
| Version Model Number | 850022550218 |
| Company DUNS | 117532009 |
| Company Name | Armbrust Inc. |
| Device Count | 20 |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | true |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com | |
| Phone | 512-807-0744 |
| support@armbrust.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850022550218 [Primary] |
| GS1 | 00850022550256 [Unit of Use] |
| FXX | Mask, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-09-13 |
| Device Publish Date | 2023-01-27 |
| 10850056441206 - Target Up&Up | 2025-01-06 USA Made Nitrile Gloves - Blue - Medium - Box of 50 |
| 00850022550003 - 3-Ply Disposable Surgical Face Masks | 2023-09-13 American Made Surgical Masks, 3-Ply Disposable Surgical Face Masks, ASTM Level 3 |
| 00850022550218 - Fold Flat Surgical Mask | 2023-09-13Flat Fold Surgical Mask, Behind the ears loops, ASTM F2100 Level 3 Rating |
| 00850022550218 - Fold Flat Surgical Mask | 2023-09-13 Flat Fold Surgical Mask, Behind the ears loops, ASTM F2100 Level 3 Rating |
| 00850022550249 - American Kid Disposable Face Maks | 2023-09-13 3-Ply Disposable Face Masks, ASTM F2100 Level 3 |