Duns Number:488293218
Device Description: Single Tubing with small connector for thoracic suction system pump
Catalog Number
-
Brand Name
Thopaz tubing single, small connector
Version/Model Number
079.0023
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
K141553,K141553
Product Code
BTA
Product Code Name
Pump, Portable, Aspiration (Manual Or Powered)
Public Device Record Key
c6565c5b-1b82-4f58-bf86-52b2b807751f
Public Version Date
June 08, 2021
Public Version Number
7
DI Record Publish Date
June 07, 2017
Package DI Number
07612367038539
Quantity per Package
10
Contains DI Package
07612367024754
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 93 |