Duns Number:004382282
Device Description: 15' LARGE BORE TUBING W/SILICONE INSERT FOR INFILTRATION PUMP SYSTEMS -SINGLE SPIKE, BOX 15' LARGE BORE TUBING W/SILICONE INSERT FOR INFILTRATION PUMP SYSTEMS -SINGLE SPIKE, BOX OF 10
Catalog Number
B89216
Brand Name
INFILTRATION TUBING
Version/Model Number
B89216
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"
-
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
GAZ
Product Code Name
Tubing, Noninvasive
Public Device Record Key
60561ced-3802-4d1a-949f-6ec0b4a80fae
Public Version Date
April 23, 2019
Public Version Number
4
DI Record Publish Date
August 19, 2016
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 |