| Primary Device ID | 36937935328587 |
| NIH Device Record Key | 325234d5-88ff-4ecc-b2d7-acbc789b3ee3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEALQU® Bordered Gauze Dressing |
| Version Model Number | 10x10cm |
| Company DUNS | 420364846 |
| Company Name | Shanghai Iso Medical Products Co., Ltd. |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06937935328586 [Primary] |
| GS1 | 36937935328587 [Package] Contains: 06937935328586 Package: BOX [15 Units] In Commercial Distribution |
| GS1 | 56937935328581 [Package] Package: Carton [10 Units] In Commercial Distribution |
| NAC | Dressing, Wound, Hydrophilic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-04 |
| Device Publish Date | 2023-07-27 |
| 36937935328594 | 10x10cm |
| 36937935328587 | 10x10cm |
| 36937935328570 | 10x6cm |
| 36937935328563 | 5x5cm |
| 36937935328617 | 15x15cm |
| 36937935328600 | 15x15cm |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HEALQU 87394469 5414435 Live/Registered |
Healqu, LLC 2017-03-31 |