Duns Number:315654579
Device Description: ATV-70 Vacuum Line is a tubing system to connect:1. ATR 40/120 reservoir with overfill pro ATV-70 Vacuum Line is a tubing system to connect:1. ATR 40/120 reservoir with overfill protector 2. ATR 40/120 reservoir with vacuum regulator of external vacuum source 3. Smoke filter with hydrophobic filter
Catalog Number
9108554
Brand Name
ATV-70 Vacuum Line
Version/Model Number
9108554
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
09272e5d-1c89-4fa5-a3c5-57d982a8c6f9
Public Version Date
March 30, 2021
Public Version Number
6
DI Record Publish Date
September 29, 2016
Package DI Number
04052682000720
Quantity per Package
15
Contains DI Package
04052682000713
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 |