ambIT* Remote Bolus Switch 220265
ambIT* Remote Bolus Switch 220265 is a Class II device made by Avanos Medical, Inc., cleared under FDA 510(k) K162165 on 29 Aug 2017 and listed in FDA GUDID since 5 Apr 2023 (UDI-DI 00193494000776), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00193494000776 | Date5 Apr 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162165 | Date29 Aug 2017 | StatusActive |
Official records
- AccessGUDID record 00193494000776
- FDA 510(k) database K162165
Across registries
- FDA 510(k) K162165 decided 29 Aug 2017 Active
- FDA GUDID UDI-DI 00193494000776 listed 5 Apr 2023 Listed
Recalls
-
- Terminated Z-1687-2023
- Terminated Z-1684-2023
- Terminated Z-1688-2023
- Terminated Z-1686-2023
- Terminated Z-1685-2023
Some of the ambIT kits were potentially distributed without an air in-line filter.
Timeline
- Cleared FDA 510(k) K162165
- Listed FDA GUDID 00193494000776
- Recall initiated FDA recalls Z-1687-2023
- Recall initiated FDA recalls Z-1684-2023
- Recall initiated FDA recalls Z-1688-2023
- Recall initiated FDA recalls Z-1686-2023
- Recall initiated FDA recalls Z-1685-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ambIT* Remote Bolus Switch
- Generic name
- Infusion pump remote control
- Model / Ref / Catalog
- 220265
- Primary DI / UDI-DI
- 00193494000776
- 510(k) Number
- FDA product code
- MEA
- GMDN term
- Infusion pump remote control
- Device class
- Class II
- Regulation number
- 880.5725
- GUDID distribution status
- In Commercial Distribution
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