Duns Number:001292192
Device Description: SYR 10ML SURESCRUB POSIFLUSH SALINE
Catalog Number
306559
Brand Name
BD PosiFlush SureScrub
Version/Model Number
306559
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121655,K121655,K121655
Product Code
LKB
Product Code Name
Pad, alcohol, device disinfectant
Public Device Record Key
6e9a31e1-ba9a-4871-9158-a4f5804352c2
Public Version Date
October 06, 2020
Public Version Number
5
DI Record Publish Date
September 19, 2016
Package DI Number
50382903065597
Quantity per Package
16
Contains DI Package
30382903065593
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 | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |