Duns Number:023904428
Device Description: Transport Recliner / Power /Colonial Blue, Trendelenburg, 2 side tables, weight capacity 3 Transport Recliner / Power /Colonial Blue, Trendelenburg, 2 side tables, weight capacity 300 lbs / overall width 32.75 in
Catalog Number
-
Brand Name
McKesson
Version/Model Number
MCK65PT45-TS73
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"
Yes
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
GBB
Product Code Name
Chair, Surgical, Ac-Powered
Public Device Record Key
c4c73414-fcc4-4fa1-9ffe-006718b1bad9
Public Version Date
June 10, 2019
Public Version Number
2
DI Record Publish Date
March 22, 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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |