Duns Number:249675476
Device Description: Medical bed.
Catalog Number
FM1000
Brand Name
Freedom 1000
Version/Model Number
FM1000
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
FNL
Product Code Name
Bed, Ac-Powered Adjustable Hospital
Public Device Record Key
6cac34e6-8f99-48ab-96cc-8719f6f1e35a
Public Version Date
February 15, 2021
Public Version Number
1
DI Record Publish Date
February 05, 2021
Package DI Number
10670482000477
Quantity per Package
1
Contains DI Package
00670482000470
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 | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 32 |