Duns Number:037304144
Device Description: Mobilecare Stretcher; Standard Features Include 5th Wheel, Dual Pneumatic Back Adjustment, Mobilecare Stretcher; Standard Features Include 5th Wheel, Dual Pneumatic Back Adjustment, 8" Tente Locking Casters, Brake Steer Pedals on all Four Corners and Both Ends, Six total, Dual Pedestal Lift Mechanism Clearly Marked Height Adjustments Pedals On Both Sides From 23" Low To 36" High ,Trendelenburg And Reverse Trendelenburg Adjustment Pedals On Both Sides, Fold Down Side Rails, Built-In O2 Cylinder Storage Underneath Stretcher Top, Two Hook Removable Slow Descent Telescopic I.V. Pole & 4"T X 27"W X 75" L Foam Mattress, Patient Surface 75"L X 29"W, Overall: 83” long x31” wide. Patient Weight Capacity 750 Pounds. With Head Rest
Catalog Number
FHC7200-EYE
Brand Name
PERSONAL TRANSPORT STRETCHER W ITH HEAD REST
Version/Model Number
FHC7200-EYE
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
88849f46-ad62-449b-a9f4-b34098361d0f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 10, 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 | 287 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |