Duns Number:216344051
Device Description: IV3000 Bulk Non Sterile
Catalog Number
66604006
Brand Name
IV3000 7X9CM NON STERILE NO POUCH
Version/Model Number
66604006
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
b426bab6-6d30-4ccd-a9b1-d7871edc9022
Public Version Date
May 17, 2021
Public Version Number
1
DI Record Publish Date
May 07, 2021
Package DI Number
05000223456399
Quantity per Package
10
Contains DI Package
05000223498467
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |
U | Unclassified | 1 |