301695
by Becton, Dickinson and Company
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00382903016952 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK021475 | Date19 Jul 2002 | StatusActive |
Recalls
-
- Terminated Z-0588-2021
BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician.
-
- Terminated Z-0207-2018
Hub damage resulting in breakage and/or leakage during use.
-
- Terminated Z-1009-2012
Becton Dickinson has identified clogged needles.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Hypodermic needle, single-use
- Model / Ref / Catalog
- 301695
- Primary DI / UDI-DI
- 00382903016952
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Hypodermic needle, single-use
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
- Size
- Needle Gauge — 22 GaugeLength — 1 Inch
Other devices from Becton, Dickinson and Company
Properties
Other properties (10)
- Sterilise before use: No
- Implantable: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Manufacturing date: No