Duns Number:008124539
Device Description: Resp-O2 Reusable Outer Suction Canister, 3000cc, Wall Mount
Catalog Number
-
Brand Name
Resp-O2 Reusable Outer Suction Canister
Version/Model Number
32252
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
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
39ef9248-8d28-40e7-92fd-a68178d01106
Public Version Date
May 17, 2022
Public Version Number
1
DI Record Publish Date
May 09, 2022
Package DI Number
00840117321519
Quantity per Package
10
Contains DI Package
00840117321571
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |