Duns Number:338664915
Device Description: Collection bag that can be connected with any gravity or active suction systems for collec Collection bag that can be connected with any gravity or active suction systems for collecting fluids from the patient.
Catalog Number
12015
Brand Name
Drentech Bag - Replacement
Version/Model Number
12015
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
GCY
Product Code Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Public Device Record Key
509d3e53-1d48-40c3-80b1-a7d0366d87c1
Public Version Date
May 12, 2021
Public Version Number
1
DI Record Publish Date
May 04, 2021
Package DI Number
18034139291687
Quantity per Package
50
Contains DI Package
08034139291680
Package Discontinue Date
-
Package Status
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 | 105 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |