Duns Number:008503294
Device Description: NC CBL & ZETT ADPTR
Catalog Number
8235NCZZ
Brand Name
POSEY
Version/Model Number
8235NCZZ
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KMI
Product Code Name
Monitor, Bed Patient
Public Device Record Key
15342c18-1071-4af8-93a8-0726ae17f0b9
Public Version Date
October 12, 2022
Public Version Number
1
DI Record Publish Date
October 04, 2022
Package DI Number
20190676004274
Quantity per Package
20
Contains DI Package
10190676004277
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 177 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |