Duns Number:051798999
Device Description: OCEAN DRAIN, DUAL, IN-LINE, STOP
Catalog Number
-
Brand Name
OCEAN
Version/Model Number
2020-000
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
K043582,K043582
Product Code
KDQ
Product Code Name
BOTTLE, COLLECTION, VACUUM
Public Device Record Key
3f0ab85b-294f-4df6-88c1-fa4215102f63
Public Version Date
October 15, 2020
Public Version Number
6
DI Record Publish Date
September 24, 2015
Package DI Number
20650862102011
Quantity per Package
6
Contains DI Package
00650862102017
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 | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 273 |