Duns Number:025460908
Device Description: SYRINGE,10U/ML HEPARIN 5ML IN 10ML
Catalog Number
EMZE050055
Brand Name
PENDING
Version/Model Number
EMZE050055
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
K133446,K133446,K133446
Product Code
NZW
Product Code Name
Heparin, vascular access flush
Public Device Record Key
d8e200a0-7bd3-4d45-b64a-ab93ea143d86
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
June 01, 2020
Package DI Number
30888277675890
Quantity per Package
600
Contains DI Package
20888277675893
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CAN
| 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 |