ICU Medical CH3386
Listed
Valid until
Not applicable
FDA recalls
1 ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840619068271 | Date27 Jul 2021 | StatusListed |
Recalls
-
- Ongoing Z-0699-2021
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- ICU Medical
- Generic Name
- Basic intravenous administration set, noninvasive
- Model / Ref / Catalog
- CH3386
- Primary DI / UDI-DI
- 00840619068271
- 510(k) Number
- FDA Product Code
- FPA
- GMDN Term
- Basic intravenous administration set, noninvasive
- Device Class
- Class II
- Regulation Number
- 880.5440
- GUDID distribution status
- In Commercial Distribution
Other devices from ICU Medical, Inc.
Properties
Other properties (9)
- 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