Duns Number:368457563
Device Description: Vests for Biliblanket® Phototherapy System, Disposable
Catalog Number
6600-0461-200
Brand Name
AirLife™
Version/Model Number
6600-0461-200
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KME
Product Code Name
Bedding, Disposable, Medical
Public Device Record Key
3d758a27-1879-45ea-a610-931d877c8a43
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 29, 2021
Package DI Number
20190752111780
Quantity per Package
10
Contains DI Package
70190752111785
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 13 |
2 | A medical device with a moderate to high risk that requires special controls. | 600 |