Duns Number:020275145
Device Description: Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 40" L
Catalog Number
278600
Brand Name
Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 40" L
Version/Model Number
Tubing, 1.5" I.D., 1 3/8"-1 3/8" Fittings, 40" L - 278600
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
-
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
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
f6777e7b-c1a0-45f7-b2e6-c08cc7e0bf45
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
January 27, 2020
Package DI Number
00817081025415
Quantity per Package
1
Contains DI Package
00817081025408
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 222 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |