Duns Number:079991657
Device Description: AUTOVAC® 792600 with 3/16" (15Fr) PVC Drain & Trocar
Catalog Number
792614
Brand Name
BOEHRINGER® AUTOVAC® 792600 with 3/16" (15Fr) PVC Drain & Trocar
Version/Model Number
792614
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2018
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
-
Product Code
CAC
Product Code Name
Apparatus, Autotransfusion
Public Device Record Key
a88074a9-798f-4893-9d7c-58f856fe3160
Public Version Date
December 22, 2020
Public Version Number
4
DI Record Publish Date
August 01, 2016
Package DI Number
40816286020681
Quantity per Package
6
Contains DI Package
10816286020680
Package Discontinue Date
December 31, 2018
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 |