Duns Number:482489007
Catalog Number
017349
Brand Name
Transfer Set
Version/Model Number
017349
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133147,K133147,K133147
Product Code
FPK
Product Code Name
Tubing, Fluid Delivery
Public Device Record Key
c12e8f24-66e5-4f40-95d9-57ab2e399f7d
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
37630039300358
Quantity per Package
100
Contains DI Package
27630039300351
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 84 |