Basic 101046565
by Medela LLC
Basic 101046565 is a Class II device made by Medela LLC, cleared under FDA 510(k) K170329 on 24 Mar 2017 (2 earlier submissions) and listed in FDA GUDID since 31 May 2024 (UDI-DI 07612367088169), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07612367088169 | Date31 May 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170329 | Date24 Mar 2017 | StatusActive |
Official records
- AccessGUDID record 07612367088169
- FDA 510(k) database K170329
- FDA 510(k) database K150134
- FDA 510(k) database K130123
Across registries
- FDA 510(k) K170329 decided 24 Mar 2017 Active
- FDA GUDID UDI-DI 07612367088169 listed 31 May 2024 Listed
Recalls
-
- Terminated Z-1502-2021
Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
Timeline
- Cleared FDA 510(k) K130123
- Cleared FDA 510(k) K150134
- Cleared FDA 510(k) K170329
- Recall initiated FDA recalls Z-1502-2021
- Listed FDA GUDID 07612367088169
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Basic
- Generic name
- Surgical suction pump
- Model / reference
- 101046565
- Primary DI / UDI-DI
- 07612367088169
- FDA product code
- BTA, GCX, QPB, MUU
- GMDN term
- Surgical suction pump
- Device class
- Class II
- Regulation number
- 878.4780, 880.6740, 878.5040
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe