Duns Number:632707092
Device Description: Sales kit containing1pc Universal holder 073257100042891 pc Table attachement 073257100042 Sales kit containing1pc Universal holder 073257100042891 pc Table attachement 07325710004272
Catalog Number
-
Brand Name
PENDANT BED/HOLDER
Version/Model Number
6693710
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
K151814,K180098,K201874
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
0bd2909c-e86b-4ca7-974c-821b76183aa3
Public Version Date
June 09, 2021
Public Version Number
5
DI Record Publish Date
January 28, 2016
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 | 62 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 131 |