NeoMagic 1946-1608
NeoMagic 1946-1608 is a Class II device made by Neo Medical Inc., cleared under FDA 510(k) K983916 on 23 Nov 1998 and listed in FDA GUDID since 11 Mar 2022 (UDI-DI B339194616080), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB339194616080 | Date11 Mar 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK983916 | Date23 Nov 1998 | StatusActive |
Official records
- FDA 510(k) database K983916
Across registries
- FDA 510(k) K983916 decided 23 Nov 1998 Active
- FDA GUDID UDI-DI B339194616080 listed 11 Mar 2022 Listed
Timeline
- Cleared FDA 510(k) K983916
- Listed FDA GUDID B339194616080
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- NeoMagic
- Generic name
- Peripheral intravenous catheterization kit, non-sensing
- Model / Ref / Catalog
- 1946-1608
- Primary DI / UDI-DI
- B339194616080
- 510(k) Number
- FDA product code
- FOZ
- GMDN term
- Peripheral intravenous catheterization kit, non-sensing
- Device class
- Class II
- Regulation number
- 880.5200
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Catheter Length — 8 CentimeterCatheter Gauge — 1.9 French
Similar devices
Other devices filed under FDA product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days).
- Cuff-Cath by Ohmeda Medical
- LEADERFLEX by VYGON
- TRULINE INFUSION CATHETERS by Micro Therapeutics, Inc.
- Safe Wing Cath (SWC) by JMS North America Corporation
- MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM by MDC Research, Ltd.
- Heparin Lock Flush Syringe by Am2 Pat, Inc.
- Leonard/Norton Hyperalimentation Cathet by Norton Performance Plastics Corp.
- BD Preefile Normal Saline Flush Syringe by Bd/Preefil
- Supercath Z3V by TOGO MEDIKIT CO., LTD.
- Safe-Cath by Scientific Device Manufacturer, LLC