Duns Number:962364444
Device Description: IV ADMIN SET, W/ GVS EASYDROP® FLOW REGULATOR,, 0.22µ IN LINE GVS SPEEDFLOW® AIR-ELIMINATI IV ADMIN SET, W/ GVS EASYDROP® FLOW REGULATOR,, 0.22µ IN LINE GVS SPEEDFLOW® AIR-ELIMINATING FILTER, DEHP-FREE, 1 Y-SITE, 15µ FILTER IN DRIP CHAMBER, SWIVEL LL, 92"
Catalog Number
-
Brand Name
Integrated Medical Specialties
Version/Model Number
IMS044G
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
52b5fd1d-a7c5-4457-a54c-6a50113d560b
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
March 17, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-