Duns Number:025460908
Device Description: 3ML ENFIT SYRINGE, AMBER
Catalog Number
NON66203
Brand Name
Medline
Version/Model Number
NON66203
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
K190502,K190502
Product Code
PNR
Product Code Name
Enteral Syringes with enteral specific connectors
Public Device Record Key
a8506fbe-7fa2-4361-a1bd-0033a5fb96d0
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
December 09, 2020
Package DI Number
20888277703671
Quantity per Package
500
Contains DI Package
10888277703674
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 | 38540 |
2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
3 | A medical device with high risk that requires premarket approval | 2 |
U | Unclassified | 7 |