| Primary Device ID | 16973495370006 |
| NIH Device Record Key | d97feff5-a872-40fa-bc24-df5ef46d52dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JUD care |
| Version Model Number | sBooth- TC1B1(E), sBooth- TC1B1 (AE) |
| Company DUNS | 420584221 |
| Company Name | Shenzhen Juding Medical 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 16973495370006 [Primary] |
| FZH | Apparatus, Air Handling, Room |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-05 |
| Device Publish Date | 2021-06-25 |
| 26973495370003 | sRoom-TC1N1B(Souc) |
| 06973495370047 | Accessory, Purification Filters, |
| 06973495370030 | Accessory, Portable Ward sRoom Carpet |
| 06973495370023 | Accessory, Portable Ward sRoom Tarpaulin |
| 16973495370006 | Portable Sampling Booth |
| 06973495370085 | Portable Sampling Booth-Consumables: Purification Filters |
| 06973495370078 | Portable Sampling Booth-Consumables: Tarpaulin |
| 06973495370061 | Portable Sampling Booth-Consumables: Carpet |