| Primary Device ID | 10840216101385 |
| NIH Device Record Key | 9ac5b3a7-5029-4de9-b0ae-af076da4ed2c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tiger Medical Products |
| Version Model Number | FMT504 |
| Company DUNS | 420944524 |
| Company Name | Tiger Medical Group |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 404-696-6999 |
| diana.rogers@aspglobal.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840216101388 [Unit of Use] |
| GS1 | 10840216101385 [Primary] |
| GS1 | 20840216101382 [Package] Package: Case [6 Units] In Commercial Distribution |
| FXX | Mask, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2016-10-01 |
| 10840216101484 | Yankauer Handle Clear High Capacity w/o Vent |
| 00840216101470 | Yankauer Regular Capacity Bulb Tip |
| 10840216101453 | OR Towel, Bulk Pack |
| 20840216101429 | Surgical Face Mask, 3 Ply, Earloops |
| 20840216101412 | Surgical Face Mask, Tie-On, Blue |
| 20840216101405 | Surgical Face mask, Tie-On White |
| 20840216101399 | Mask Surgical, Tie-On, Anti-Fog |
| 10840216101385 | Isolation Mask Earloops Yellow |
| 20840216101337 | Digital Thermometer--30 Sec Read Time |