Duns Number:602736795
Device Description: Swaddler for PhotoTherapy, preemie
Catalog Number
1100
Brand Name
BIONIX DEVELOPMENT CORPORATION
Version/Model Number
NP-1100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123411,K123411
Product Code
PDH
Product Code Name
blanket, neonatal phototherapy
Public Device Record Key
9e39be77-e760-4a35-a5be-50d09f24313d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 01, 2017
Package DI Number
00859911004276
Quantity per Package
10
Contains DI Package
10859911004273
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |