Duns Number:315578914
Catalog Number
-
Brand Name
CAP (7 MM)
Version/Model Number
8401645
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
BZO
Product Code Name
Set, Tubing And Support, Ventilator (W Harness)
Public Device Record Key
4fb4c640-9c50-491f-9c0b-d41b8ed4e6cb
Public Version Date
October 21, 2020
Public Version Number
5
DI Record Publish Date
October 24, 2015
Package DI Number
04048675121862
Quantity per Package
5
Contains DI Package
04048675267867
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 220 |
2 | A medical device with a moderate to high risk that requires special controls. | 160 |