Tracoe Care
TRACOE tube clean Cleaning powder
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (1), Guangdong (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
Record
| Listed by | Tracoe Medical Gmbh, Germany |
|---|---|
| FDA product code | OGV |
| Device type | Tracheostomy Cleaning Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-17 |
| Record revised | 2024-11-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from rain. Keep away from sunlight. |
| Sizes | Total volume 1000 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REF 934 | Total Volume 1000 ml | In distribution |
| REF 932 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 25 |
| AirLife | Carefusion | 6 |
| Cardinal Health | Cardinal Health 200, LLC | 6 |
| Professional Medical Surgical Supply, Inc. d / b / a International Direct | Professional Medical-Surgical Supply, Incorporated | 2 |
| Medical Equipment Affiliates | Medline Industries, 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.