Duns Number:071595540
Device Description: SUCTION CONNECTING TUBING 12 FEET LONG (3.7M), 1/4 INCHES I.D. (6.4MM)
Catalog Number
9036550
Brand Name
NA
Version/Model Number
9036550
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
-
Product Code
BYY
Product Code Name
TUBE, ASPIRATING, FLEXIBLE, CONNECTING
Public Device Record Key
6b02a5c5-2ba8-4d27-8a14-339d35d39778
Public Version Date
June 08, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20653405015014
Quantity per Package
50
Contains DI Package
30653405015011
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 |