Duns Number:644544504
Device Description: The Sprint Stretcher transport bed in its basic option used for transport and for X-ray sc The Sprint Stretcher transport bed in its basic option used for transport and for X-ray scanning is designed for the transport of critical patients being admitted in emergency conditions.
Catalog Number
-
Brand Name
Sprint 100
Version/Model Number
1ES10002
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
FPO
Product Code Name
Stretcher, Wheeled
Public Device Record Key
a87d319f-aa17-42e9-bfd5-ba7c03ccc1f3
Public Version Date
May 10, 2018
Public Version Number
1
DI Record Publish Date
April 09, 2018
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 196 |