Duns Number:071595540
Device Description: AirSeal Bifurcated Filtered Tubeset with Activated Charcoal Filter
Catalog Number
ASM-EVAC1-Bi
Brand Name
AirSeal
Version/Model Number
ASM-EVAC1-Bi
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
K211104,K211104,K211104
Product Code
HIF
Product Code Name
Insufflator, laparoscopic
Public Device Record Key
ccee6c90-96bc-4d1f-8396-a96471fdceff
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
August 22, 2021
Package DI Number
20845854051402
Quantity per Package
1
Contains DI Package
10845854051405
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |