Swaddler for Phototherapy
Swaddler for PhotoTherapy: Newborn, regular
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
Record
| Listed by | Bionix, LLC, United States |
|---|---|
| FDA product code | PDH |
| Device type | Blanket, Neonatal Phototherapy |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5700 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K123411 |
| Record published | 2017-02-01 |
| Record revised | 2024-04-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2024-04-10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1100 | 10 | Withdrawn | |
| 1105 | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Blanket, Neonatal Phototherapy | Salter Labs | 3 |
| Bionix Development Corporation | M&H Medical Holdings, Inc. | 2 |
| Bionix Development Corporation | Bionix, LLC | 2 |
| Advanced Phototherapy Lamp | Advanced Instrumentations, 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.