Duns Number:249675476
Device Description: AC-powered medical bed with 4 built-in electric DC actuators that offers a powered adjustm AC-powered medical bed with 4 built-in electric DC actuators that offers a powered adjustment of the height and surface contours. Bed includes movable and latchable siderails or patient mobilization helper, and control boards. The deck can be manually extended of 4” with the integrated bed length extender and reach 84” or 88” long. The deck width can be manually extended from 35” up to 47”. The product offers a range of options and accessories including but not limited to integrated scale, integrated bed exit system, bed status monitoring, Pilot Drive, fixed or foldable IV pole, patient helper, oxygen bottle holder and length extension cushions.
Catalog Number
200-0000
Brand Name
ook snow ALL
Version/Model Number
200-0000
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
fb015e98-3094-4f2b-bf9e-6222fc8bd091
Public Version Date
June 14, 2021
Public Version Number
1
DI Record Publish Date
June 04, 2021
Package DI Number
10670482000491
Quantity per Package
1
Contains DI Package
00670482000494
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 |