Duns Number:141668116
Device Description: Suction Kit (1 Kit), This Kit Contains: 1 RES025 Suction Tubing 6ft, 1 BF516TS Bacteria Fi Suction Kit (1 Kit), This Kit Contains: 1 RES025 Suction Tubing 6ft, 1 BF516TS Bacteria Filter 5/16in Barbed with Threaded NPT, 1 RES024XL Suction Tube Connector 16in, 1 RES023S Suction Canister 800cc, 1 RES028 Rubber Suction Elbow Connector.
Catalog Number
APRO030SKIT
Brand Name
Suction Kit
Version/Model Number
APRO030SKIT
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
-
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
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
5d41c131-63fa-48a9-a93a-c263991681b0
Public Version Date
July 11, 2018
Public Version Number
2
DI Record Publish Date
May 29, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |