Blanket, Neonatal Phototherapy
Luma Wrap, extra large
1manufacturer
3catalogue numbers in this listing
1510(k) clearance
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 | Salter Labs, 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) | K142416 |
| Record published | 2017-01-30 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Pack of 25, pack of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LW-102 | Small | In distribution |
| LW-105 | Extra Large | In distribution |
| LW-103 | Medium | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bionix Development Corporation | M&H Medical Holdings, Inc. | 2 |
| Bionix Development Corporation | Bionix, LLC | 2 |
| Swaddler for Phototherapy | Bionix, LLC | 2 |
| Advanced Phototherapy Lamp | Advanced Instrumentations, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142416 | 2015-06-12 |
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.