Duns Number:054164587
Device Description: BED,HOMECARE 42 X 86" 650 LB 3 FUNCTION BEECHWOOD FRAME,DECORATIVE STYLE HEADBOARD/FOOT BED,HOMECARE 42 X 86" 650 LB 3 FUNCTION BEECHWOOD FRAME,DECORATIVE STYLE HEADBOARD/FOOTBOARD OF CHOCOLATE PEAR COLOR,FULL PLASTIC SIDERAILS (HEAD END ONLY),FOOT END CONTROLS ON FOOTBOARD FOR BACKREST, LEG, BED, UP AND DOWN. ALSO LOCKOUTS FOR ANY OR ALL FUNCTIONS.
Catalog Number
-
Brand Name
NA
Version/Model Number
3642HC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 15, 2020
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
-
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
2b90d729-8834-45e4-87d9-0d8d7e17bf8b
Public Version Date
November 16, 2021
Public Version Number
3
DI Record Publish Date
September 23, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 262 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |