Duns Number:004382282
Device Description: 13' SOFTOUCH INFILTRATION TUBING WITH 2 BLUE MOLDED CONNECTORS, STERILE, LATEX FREE, 10/B 13' SOFTOUCH INFILTRATION TUBING WITH 2 BLUE MOLDED CONNECTORS, STERILE, LATEX FREE, 10/BOX
Catalog Number
B89210
Brand Name
N/A
Version/Model Number
B89210
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
BYY
Product Code Name
TUBE, ASPIRATING, FLEXIBLE, CONNECTING
Public Device Record Key
4b25721e-7454-40bf-8a0b-b2f67cfe4611
Public Version Date
September 20, 2022
Public Version Number
1
DI Record Publish Date
September 12, 2022
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 | 5533 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 240 |