Duns Number:832696038
Device Description: HIGH FLOW INSUFFLATION TUBING WITH ROTATING LUER LOCK, .3 MICRON FILTER, 10 FT. 20 EACH/BO HIGH FLOW INSUFFLATION TUBING WITH ROTATING LUER LOCK, .3 MICRON FILTER, 10 FT. 20 EACH/BOX
Catalog Number
LA103-RLL
Brand Name
V. Mueller
Version/Model Number
LA103-RLL
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
NKC
Product Code Name
Tubing/tubing with filter, insufflation, laparoscopic
Public Device Record Key
f8204492-90c7-48f0-a937-c0bbc0dddbc8
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
August 30, 2018
Package DI Number
20885403240888
Quantity per Package
20
Contains DI Package
10885403240881
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |