Duns Number:315654579
Device Description: The ATV-F140C Vacuum Lines Combi-pack consists of:1: vacuum tube with integrated filter2: The ATV-F140C Vacuum Lines Combi-pack consists of:1: vacuum tube with integrated filter2: vacuum tube including clamp and yellow cap3: "smoke connector"
Catalog Number
9008554
Brand Name
ATV-F140C Vacuum Lines Combi-pack
Version/Model Number
9008554
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
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
CAC
Product Code Name
Apparatus, Autotransfusion
Public Device Record Key
91a55e23-059d-4b5f-8d9f-fda08be29429
Public Version Date
March 30, 2021
Public Version Number
4
DI Record Publish Date
March 09, 2018
Package DI Number
04052682011467
Quantity per Package
12
Contains DI Package
04052682011450
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 2 |