Duns Number:008124539
Device Description: Resp-O2 Disposable Suction Canisters, 800cc, Float Valve Shutoff, Locking Lid, 3/16" x 6' Resp-O2 Disposable Suction Canisters, 800cc, Float Valve Shutoff, Locking Lid, 3/16" x 6' and 3/16" x 18" Tubing with Male Connector
Catalog Number
-
Brand Name
Resp-O2 Disposable Suction Canisters
Version/Model Number
32201
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
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
0bb861f2-456e-4d08-9105-1c904afdec23
Public Version Date
May 06, 2022
Public Version Number
1
DI Record Publish Date
April 28, 2022
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |