BluWing MER 1923
BluWing MER 1923 is a Class II device made by Mercedes Medical LLC, cleared under FDA 510(k) K163093 on 14 Mar 2017 and listed in FDA GUDID since 1 Jul 2017 (UDI-DI 00850011007235), 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 | Number00850011007235 | Date1 Jul 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163093 | Date14 Mar 2017 | StatusActive |
Official records
- AccessGUDID record 00850011007235
- FDA 510(k) database K163093
Across registries
- FDA 510(k) K163093 decided 14 Mar 2017 Active
- FDA GUDID UDI-DI 00850011007235 listed 1 Jul 2017 Listed
Timeline
- Cleared FDA 510(k) K163093
- Listed FDA GUDID 00850011007235
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BluWing
- Generic name
- Venous butterfly needle/set
- Model / Ref / Catalog
- MER 1923
- Primary DI / UDI-DI
- 00850011007235
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Venous butterfly needle/set
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FMI (Needle, Hypodermic, Single Lumen).
- IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR by Ziehm International, Inc.
- MEDIPOINT MULTI-SAMPLE BLOOD COLLECTING NEEDLE by Medi Point, Inc.
- BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA by Bd Becton Dickinson Vacutainer Systems Preanalytic
- MEDT PEN NEEDLE by Shandong Caremed Medical Products Co., Ltd
- Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel by MEDBIO, LLC.
- Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set by Sol-Millennium Medical, Inc.
- Clickfine AutoProtect Pen Needle by Ypsomed AG
- VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER by Kawasumi Laboratories Co., Ltd.
- TERUMO SURGUARD2 SAFETY NEEDLE by TERUMO MEDICAL CORPORATION
- EXEL COMFORTPOINT INSULIN PEN NEEDLE by Exelint Intl. Co.