Duns Number:188660844
Device Description: MOBILECARE STRETCHER WITH PNEUMATIC BACK ADJUSTMENT. CLEARLY MARKED HEIGHT ADJUST PEDALS MOBILECARE STRETCHER WITH PNEUMATIC BACK ADJUSTMENT. CLEARLY MARKED HEIGHT ADJUST PEDALS ON BOTH SIDES WITH RANGE OF 23" TO 36". TRENDELENBURG AND REVERSE TRENDELEBURG ADJUSTMENT PEDALS ON BOTH SIDES. FOLD DOWN SIDE RAILS. BUILT IN O2 CYLINDER STORAGE. CENTRAL LOCKING CASTERS. BRAKE/STEER PEDAL AT EACH CORNER. I.V. POLE AND 4" FOAM MATTRESS INCLUDED. WEIGHT CAPACITY 550LB
Catalog Number
NK8000
Brand Name
PERSONAL TRANSPORT STRETCHER
Version/Model Number
NK8000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
FPO
Product Code Name
Stretcher, Wheeled
Public Device Record Key
4ecd8393-af0f-4734-8e38-f0359169beaa
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 13, 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 | 456 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |