Duns Number:025460908
Device Description: TUBING, SUCTION, 1/4" X 6', SCALLOP
Catalog Number
DYND50246
Brand Name
Medline
Version/Model Number
DYND50246
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
BYY
Product Code Name
TUBE, ASPIRATING, FLEXIBLE, CONNECTING
Public Device Record Key
d553c240-3aa1-4a64-be98-6edfae926f8a
Public Version Date
April 25, 2022
Public Version Number
1
DI Record Publish Date
April 15, 2022
Package DI Number
40080196035190
Quantity per Package
50
Contains DI Package
10080196035199
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |