Infant Positioner, Rx, Use In Highly Monitored Setting
OUW is the FDA product code for Infant Positioner, Rx, Use In Highly Monitored Setting, a class I device type, regulated under 21 CFR 880.5680. FDA's definition for this code reads: "Designed to position the baby at a 30 degree angle in the prone (on his/her stomach) position for specific medical or surgical conditions. For use only when in a highly monitored setting with continuous cardio-respiratory and oxygen saturation monitoring". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- OUW
- Device name
- Infant Positioner, Rx, Use In Highly Monitored Setting
- FDA definition
- Designed to position the baby at a 30 degree angle in the prone (on his/her stomach) position for specific medical or surgical conditions. For use only when in a highly monitored setting with continuous cardio-respiratory and oxygen saturation monitoring.
- Regulation
- 21 CFR 880.5680
- Device class
- Class I
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 2
Clearances, product code OUW
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2018 | 1 |
Applicants with the most clearances
Product code OUW| Applicant | Clearances |
|---|---|
| Neonatal Loving Kare, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code OUW.
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