Duns Number:825673239
Device Description: AMSure® Suction Catheter Tray SIZE:8Fr.CONTENTS:1 each Catheter1 pair of Yellow Colored Vi AMSure® Suction Catheter Tray SIZE:8Fr.CONTENTS:1 each Catheter1 pair of Yellow Colored Vinyl Gloves1 bottle Sterile 0.9% Saline Solution, 100mL
Catalog Number
AS392C
Brand Name
AMSure® Suction Catheter Tray
Version/Model Number
1
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
BSY
Product Code Name
Catheters, Suction, Tracheobronchial
Public Device Record Key
7937a652-3cec-4a25-925b-1e2c22f3d170
Public Version Date
July 13, 2018
Public Version Number
1
DI Record Publish Date
June 12, 2018
Package DI Number
40704411008768
Quantity per Package
36
Contains DI Package
10704411008767
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 | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |