Duns Number:126830020
Device Description: LS7010 8' Aspiration Tubing
Catalog Number
LS7010
Brand Name
MD Resource
Version/Model Number
LS7010
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"
Yes
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
BYY
Product Code Name
Tube, Aspirating, Flexible, Connecting
Public Device Record Key
9f2c7f12-e7b6-41e8-930c-acf7c0c6b87b
Public Version Date
June 08, 2021
Public Version Number
5
DI Record Publish Date
August 30, 2016
Package DI Number
00859898006140
Quantity per Package
4
Contains DI Package
00859898006010
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 12 |