0.9% Sodium Chloride Injection Usp Bd Posiflush Flush Syringe, Sf Flush Syringe
510(k) K121050
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121050 | Date7 Feb 2013 | StatusActive |
Recalls
-
- Terminated Z-2673-2014
BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NGT
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent