Duns Number:071426803
Device Description: 6 ft. long x 1.3" diameter hose with connector for use with TX Pack or LTX Pack
Catalog Number
-
Brand Name
ACU-EVAC
Version/Model Number
HOSE
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K930043
Product Code
FYD
Product Code Name
Apparatus, Exhaust, Surgical
Public Device Record Key
ff1bdff0-1f0d-4ca9-93b8-0c977fe29d8e
Public Version Date
January 13, 2020
Public Version Number
1
DI Record Publish Date
January 03, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 61 |