Duns Number:141668116
Device Description: Carry Bag for Portable Suction Machine
Catalog Number
SU100DC-BAG
Brand Name
Carry Bag for Portable Suction Machine
Version/Model Number
SU100DC-BAG
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
44f822c6-92e5-4332-9898-a9887e8f0ca2
Public Version Date
April 21, 2021
Public Version Number
5
DI Record Publish Date
May 25, 2018
Package DI Number
10848530089211
Quantity per Package
4
Contains DI Package
00848530089214
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 | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |