Duns Number:632707092
Device Description: Contains 5 pc of:6694192 Luer cap, disposable 4.3M6694182 Angled Y-piece 15F, 10M*2
Catalog Number
-
Brand Name
Y-PIECE W/SAMPL. PORT
Version/Model Number
6880253
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
d7eb6519-7604-462b-9f84-bb60932cc09f
Public Version Date
May 28, 2019
Public Version Number
4
DI Record Publish Date
January 31, 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 |