Duns Number:656854379
Catalog Number
Hytrel hose10F cuff,L= 30 cm
Brand Name
N/A
Version/Model Number
77641
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
BZO
Product Code Name
Set, Tubing And Support, Ventilator (W Harness)
Public Device Record Key
08ff3069-b833-4881-b56b-bf2efc1842e7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 15, 2015
Package DI Number
44710810088627
Quantity per Package
60
Contains DI Package
04710810088629
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 29 |
2 | A medical device with a moderate to high risk that requires special controls. | 22 |