| Primary Device ID | 36937935328600 | 
| NIH Device Record Key | 6749288d-e335-4c7b-b486-89113a1ec11c | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | HEALQU® Bordered Gauze Dressing | 
| Version Model Number | 15x15cm | 
| 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 | 06937935328609 [Primary] | 
| GS1 | 36937935328600 [Package] Contains: 06937935328609 Package: box [15 Units] In Commercial Distribution | 
| GS1 | 56937935328604 [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 | 2023-08-07 | 
| Device Publish Date | 2023-07-28 | 
| 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 |