Duns Number:079991657
Device Description: AUTOVAC® Modular Collection Module with Disconnect
Catalog Number
792600
Brand Name
BOEHRINGER® AUTOVAC® Modular Collection Module with Disconnect
Version/Model Number
792600
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2017
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
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
K932093,K932093
Product Code
CAC
Product Code Name
Apparatus, Autotransfusion
Public Device Record Key
4ed68919-4941-4eaa-865e-b269b6c12f59
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 01, 2016
Package DI Number
40816286020667
Quantity per Package
6
Contains DI Package
10816286020666
Package Discontinue Date
September 01, 2017
Package Status
Not in Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 85 |