Medline
DBD-CATHETER,SUCTION,8FR,DELEE,W/SLEEVE,
9manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OFR |
| Device type | Tracheobronchial Suction Catheter Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 868.6810 |
| Premarket notification | Exempt |
| Record published | 2016-10-14 |
| Record revised | 2022-11-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: Avoid excessive heat. Protect from freezing. |
| Packaging | Case of 100, case of 50, pack of 50, pack of 100, ct of 100, box of 50 |
| Sizes | Catheter gauge 12 Fr |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DYND40982 | In distribution | ||
| DYND40708 | 50 | In distribution | |
| DYND40976 | In distribution | ||
| DYND40983 | In distribution | ||
| DYND40980 | In distribution | ||
| DYND40702F | In distribution | ||
| DYND40980LG | In distribution | ||
| DYND40700F | In distribution | ||
| DYND40701F | Catheter Gauge 12 Fr | In distribution | |
| DYND40984 | In distribution | ||
| DYND41908C | In distribution | ||
| DYND40981 | In distribution | ||
| DYND40988 | In distribution | ||
| DYND48980A | In distribution | ||
| DYND40708F | In distribution | ||
| DYND40701 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 51 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 2 |
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.