Duns Number:428717469
Device Description: This device is a multi-functional aid capable of holding all the receptacles commonly used This device is a multi-functional aid capable of holding all the receptacles commonly used in hospital, such as bedpans,urine bottle, suction bottle, bucket etc.With the use of a removable dedicated rack on slides, this device can be also for washing and disinfection (low intermediate) small objects.
Catalog Number
BP 100 HSER
Brand Name
Steelco
Version/Model Number
BP 100 HSER
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
FLH
Product Code Name
Washer Of Body Waste Receptacles
Public Device Record Key
d4d835f3-3eb7-416f-a98e-fdd263082c3f
Public Version Date
November 25, 2019
Public Version Number
1
DI Record Publish Date
November 17, 2019
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 | 44 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 83 |