| Primary Device ID | 06972403420089 |
| NIH Device Record Key | dc472ab6-3163-45bb-bad2-e540a2cead8e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BGEcare Self Adhesive Non-woven Bandage |
| Version Model Number | CB080405011806NS |
| Company DUNS | 544509489 |
| Company Name | Henan Zhende Medical Products Co., Ltd. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06972403420072 [Primary] |
| GS1 | 06972403420089 [Package] Contains: 06972403420072 Package: box [18 Units] In Commercial Distribution |
| GS1 | 06972403420096 [Package] Package: carton box [6 Units] In Commercial Distribution |
| FQM | Bandage, Elastic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-16 |
| Device Publish Date | 2021-03-08 |
| 06972403420089 | BGEcare Self Adhesive Non-woven Bandage, 4in X 5yards, 1 roll/OPP film, 18 rolls/box, 6 boxes/ca |
| 06972403420058 | BGEcare Self Adhesive Non-woven Bandage, 2in X 5yards, 1 roll/OPP film, 36 rolls/box, 6 boxes/ca |