Duns Number:079374086
Device Description: MedSurg Overlay (33" Wide)
Catalog Number
-
Brand Name
DabirAir Micropressure
Version/Model Number
DA-3S3584-05-0L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FNM
Product Code Name
Mattress, Air Flotation, Alternating Pressure
Public Device Record Key
4b17da5c-bc48-4cd4-93f2-a1c1764b00e4
Public Version Date
May 22, 2019
Public Version Number
1
DI Record Publish Date
May 14, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 104 |