Duns Number:207372814
Device Description: A convenient and safer toilet alternative for persons with reduced mobility. Also use for A convenient and safer toilet alternative for persons with reduced mobility. Also use for support over a toilet or as a raised toilet seat.• Easy Tool-Free Assembly!• Multi-use design• Height adjustable• Rust-resistant• Plastic armrests• Durability Tested• Weight capacity: 300 lbs (136 kg)• Recommended for home use.
Catalog Number
-
Brand Name
Avantia Portable Steel Commode
Version/Model Number
771-315
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
INB
Product Code Name
Attachment, Commode, Wheelchair
Public Device Record Key
1718fcdb-4cac-4a1a-9978-cdadc4dd95b9
Public Version Date
April 24, 2020
Public Version Number
1
DI Record Publish Date
April 16, 2020
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |