Duns Number:600111512
Device Description: SURE VENTLINE SET ADULT/PEDIATRIC
Catalog Number
-
Brand Name
Surestream
Version/Model Number
012690
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"
Yes
For Single-Use
Yes
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
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
578b5d99-4767-4a05-82fc-e50f0082e2ea
Public Version Date
August 05, 2022
Public Version Number
8
DI Record Publish Date
November 09, 2017
Package DI Number
10884521552227
Quantity per Package
25
Contains DI Package
20884521552224
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 154 |