Duns Number:544543513
Device Description: The syringes are intended to inject fluids into or withdraw fluids from the body.
Catalog Number
SN01100L
Brand Name
CAINA
Version/Model Number
100ml LL
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"
Yes
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
K113091,K113091,K113091
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
8688f7ba-ee5a-4ace-8394-cd5ed84d065c
Public Version Date
June 28, 2022
Public Version Number
1
DI Record Publish Date
June 20, 2022
Package DI Number
16971564465875
Quantity per Package
15
Contains DI Package
06971564465878
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-