Duns Number:556093219
Device Description: Insufflation Tubing, Dual Luer Lock, Non-Sterile
Catalog Number
-
Brand Name
Tech-Medical Services
Version/Model Number
TMITF10NS
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NKC
Product Code Name
Tubing/Tubing With Filter, Insufflation, Laparoscopic
Public Device Record Key
09027554-99b0-470a-adab-878012281e72
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
June 26, 2021
Package DI Number
10851695005248
Quantity per Package
50
Contains DI Package
00851695005241
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |