Duns Number:079811425
Device Description: AIR-MATT 50"/127CM WIDE X 78"/198CM LONG SPU
Catalog Number
-
Brand Name
AIR MATT
Version/Model Number
AM50D
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
FMR
Product Code Name
Device, Transfer, Patient, Manual
Public Device Record Key
265808c0-c6ef-4f32-b248-2cf3d698707a
Public Version Date
September 20, 2018
Public Version Number
1
DI Record Publish Date
August 20, 2018
Package DI Number
10854564008043
Quantity per Package
5
Contains DI Package
00854564008046
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box of 5
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |