Duns Number:196548481
Device Description: Drip Reduction Manifold
Catalog Number
0700-040-000
Brand Name
NA
Version/Model Number
0700040000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 01, 2021
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
-
Product Code
FYD
Product Code Name
APPARATUS, EXHAUST, SURGICAL
Public Device Record Key
e488724c-cae9-42ba-9c83-865f1137a6aa
Public Version Date
August 30, 2021
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
34546540916793
Quantity per Package
10
Contains DI Package
04546540916792
Package Discontinue Date
April 01, 2021
Package Status
Not in Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2188 |
2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
U | Unclassified | 60 |