Duns Number:041810693
Catalog Number
9525A
Brand Name
100 in (254 cm) Q2 MultiPort IV administration set
Version/Model Number
9525A
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
FPK
Product Code Name
Tubing, Fluid Delivery
Public Device Record Key
68f7ea1c-29d6-443f-9e39-359c59ed9540
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 26, 2016
Package DI Number
20634624952519
Quantity per Package
48
Contains DI Package
00634624952515
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 168 |
U | Unclassified | 8 |