Medline
PML 72 Pediatric FLL-MLL
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Yearstar Healthcare Technology Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 43 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | DRI |
| Device type | Monitor, Line Isolation |
| Device class | Class 1 |
| Regulation | 21 CFR 870.2620 |
| Premarket notification | Exempt |
| Record published | 2023-09-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | expiry date, manufacturing date |
| Packaging | Box of 25, case of 100 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90711722UAB | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Namic | Navilyst Medical, Inc. | 61 |
| Namic | Medline Industries, Inc. | 61 |
| Medline Industries, Inc. | Medline Industries, Inc. | 5 |
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.