Duns Number:037304144
Device Description: EYE MOBILE-CARE STRETCHER WITH CLEARLY MARKED HEIGHT ADJUSTMENT PEDALS ON BOTH SIDES FROM EYE MOBILE-CARE STRETCHER WITH CLEARLY MARKED HEIGHT ADJUSTMENT PEDALS ON BOTH SIDES FROM 23"TO 36" HIGH. TRENDELEBURG AND REVERSE TRENDELENBURG ADJUSTMENT PEDALS ON BOTH SIDES. CRANK BACKREST AND KNEE GATCH.DUAL ARTICULATION TAPERED HEADPIECE. FOLD DOWN SIDE RAILS. BUILT IN O2 CYLINDER STORAGE. CENTRAL LOCKING CASTERS.BRAKE/STEER PEDAL AT EACH CORNER. I.V. POLE AND 4" MATTRESS INCLUDED. PATIENT SURFACE 88" X 26" WITH 550 LB CAPACITY.
Catalog Number
FHC7100-EYE
Brand Name
TRANSPORT STRETCHER
Version/Model Number
FHC7100-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
65fd896f-8e89-416b-986b-01f49e4d7b1a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 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 |