Definition: Is Intended To Be Used As An Adjunct To Neonatal Phototherapy Systems Used For The Treatment Of Neonatal Hyperbilirubinemia In The Clinical Or Home Setting.
| Device Type ID | 2737 |
| Device Name | Blanket, Neonatal Phototherapy |
| Physical State | Comprised Of A Light-weight, Spun Bond Polypropylene Material. Spun Bond Polypropylene Is A Commonly Used Fabric In Medical Products And Garments. The Material Is Non-irritating To The Skin, Soft, And Allows It To Easily Conform To Body Contours. The |
| Technical Method | Comprised Of A Light-weight, Spun Bond Polypropylene Material. The Blanket Is Intended To Allow An Infant Undergoing Phototherapy For Hyperbilirubinemia To Be Tightly Swaddled And Still Receive The Full Benefit Of The Phototherapy Treatment. The Desi |
| Target Area | Whole Body. |
| Regulation Description | Neonatal Phototherapy Unit. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PDH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2737 |
| Device | Blanket, Neonatal Phototherapy |
| Product Code | PDH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Neonatal Phototherapy Unit. |
| CFR Regulation Number | 880.5700 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SALTER LABS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beevers Manufacturing & Supply, Inc. | II | Aug-10-2014 |