Isolaer Aerosol Isolation Barrier
The IB Device is a procedure site barrier (i.e. drape) that surrounds a surgical site that minimizes exposure of aerosols during ENT procedures.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (3), Guangxi (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang | Hebei | Manufacturer | 29 |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
| Jiangsu Medplus NON-Woven Manufacturer Co., Ltd. | Siyang | Jiangsu | Manufacturer | 21 |
| Jiangsu Hanheng Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | Inquis Medical, Inc., United States |
|---|---|
| FDA product code | ERY |
| Device type | Drape, Surgical, Ent |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-02-03 |
| Record revised | 2022-11-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2021-03-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IB-1000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Convertors | Cardinal Health 200, LLC | 46 |
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| Hepro.us Surgical/Examination Suit M | Hepro.us Inc. | 1 |
| Hepro.us Welcome Pack – Case | Hepro.us Inc. | 1 |
| Hepro.us General Pack 1 Pouch | Hepro.us Inc. | 1 |
| Hepro.us Surgical Scrub Suit 50pcs per Case | Hepro.us Inc. | 1 |
| Hepro.us Welcome Pack | Hepro.us Inc. | 1 |
| Hepro. US General Pack – 10 Pouches-Case | Hepro.us Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.