Medline Industries, Inc.
KIT Nebulizer-LF
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Avita (Wujiang) Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 15 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OGG |
| Device type | Humidifier Nebulizer Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5450 |
| Premarket notification | Exempt |
| Record published | 2022-01-02 |
| Record revised | 2023-08-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 8 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJAA260 | In distribution | |
| DYKM1045 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 156 |
| Hudson RCI | Medline Industries, Inc. | 12 |
| AirLife | Carefusion | 10 |
| AirLife™ | Airlife, Inc. | 9 |
| Yirdoc | Qingdao Future Medical Technology Co., Ltd. | 4 |
| Composite Respiratory Kit | Westmed, Inc. | 1 |
| Seattle PAP plus | Drägerwerk AG & Co. KGaA | 1 |
| Curaplex | Bound Tree 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.