Zorro-Flow Inc.
Zorro-Flow Extra-Small Female Urine Collection System Assembly of 1 Unit
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
Record
| Listed by | Zorroflow LLC |
|---|---|
| FDA product code | FOC |
| Device type | Bag, Urine Collection, Newborn |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5250 |
| Premarket notification | Exempt |
| Record published | 2024-11-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 6, box of 12 |
| Sizes | Weight 2.5 to 6 kg |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZF-F-XS Assembly | Weight 2.5 kg | In distribution |
| ZF-F-S Assembly | Weight 6 kg | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mabis DMI | D-M-S Holdings, Inc. | 13 |
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.