Duns Number:825673239
Device Description: 3/8 inch I.D. x 5/8 inch O.D. x 10 Feet length Heavy Duty Suction Tube
Catalog Number
-
Brand Name
AMSure ® Suction Connecting Tube
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 20, 2022
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
3c6e39be-d7c3-443a-84b5-2cd2095f841a
Public Version Date
January 28, 2022
Public Version Number
1
DI Record Publish Date
January 20, 2022
Package DI Number
40704411014769
Quantity per Package
10
Contains DI Package
10704411014768
Package Discontinue Date
January 20, 2022
Package Status
Not 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 |