Duns Number:051798999
Device Description: DRAIN, SINGLE W/S, TYVEK
Catalog Number
-
Brand Name
OCEAN
Version/Model Number
2002-330
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2017
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
e34ff9a8-b301-4f85-9603-e432c6ee166d
Public Version Date
October 15, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
20650862100192
Quantity per Package
6
Contains DI Package
00650862100198
Package Discontinue Date
October 31, 2017
Package Status
Not 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 |