Duns Number:196548481
Device Description: Tubing with Wand
Catalog Number
0700026000
Brand Name
NA
Version/Model Number
0700026000
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
-
Product Code
JCX
Product Code Name
APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Public Device Record Key
155ec833-9f51-4d77-867d-038d9b1a0922
Public Version Date
January 20, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
34546540916700
Quantity per Package
10
Contains DI Package
04546540916709
Package Discontinue Date
-
Package Status
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 |