Duns Number:835917212
Device Description: PVC Bariatric Reclining Shower gurney
Catalog Number
ABSG200W5-600
Brand Name
Healthline Medical Products
Version/Model Number
ABSG200W5-600
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
April 11, 2025
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
54c490d2-c76b-4da5-b9d2-7f24b712b5e1
Public Version Date
March 26, 2021
Public Version Number
1
DI Record Publish Date
March 18, 2021
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |