Duns Number:192135242
Device Description: PMI Insufflation Tubing 10ft, .01 Micron Filter with Swivel Luer Connector
Catalog Number
PMI-10
Brand Name
PMI
Version/Model Number
PMI-10
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
cc197aae-fe99-4167-a0b9-7b494af9df5e
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
10812608020123
Quantity per Package
10
Contains DI Package
00812608020126
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |