Grafco
Berman Oral Airway (60MM) SML Child
2manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangxi (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
Record
| Listed by | GF Health Products, Inc, United States |
|---|---|
| FDA product code | PHS |
| Device type | Oral Airway Assist |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5110 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-10-09 |
| Record revised | 2025-10-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2023-03-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3786-12#3 | 12 | In distribution | |
| 3786B#0 | 100 | In distribution | |
| 3786-12#0 | 12 | In distribution | |
| 3786B#1 | 100 | In distribution | |
| 3786-12#1 | 12 | In distribution | |
| 3786-12#2 | 12 | Withdrawn | |
| 3786-12#4 | 12 | Withdrawn | |
| 3786B#2 | 100 | Withdrawn | |
| 3786 KT | 6 | Withdrawn | |
| 3786-12#5 | 12 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaplex | Bound Tree Medical, LLC | 3 |
| CarboTrack | Jada Medical LLC | 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.