Duns Number:025460908
Device Description: DBD-SYRINGE,100U/ML HEPARIN 5ML IN 10ML
Catalog Number
EMZH60051
Brand Name
PENDING
Version/Model Number
EMZH60051
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
Product Code
NZW
Product Code Name
Heparin, vascular access flush
Public Device Record Key
db076159-5be0-4174-bb78-0be2cbdba09c
Public Version Date
August 31, 2020
Public Version Number
1
DI Record Publish Date
August 21, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |