MR Na/K Check Solution 105-011386-00
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06936415904661 | Date23 Jan 2026 | StatusListed |
Recalls
-
- Terminated Z-0920-2020
- Terminated Z-0921-2020
The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- MR Na/K Check Solution
- Generic Name
- Potassium (K+) IVD, kit, ion-selective electrode (ISE)
- Model / Reference
- 105-011386-00
- Primary DI / UDI-DI
- 06936415904661
- 510(k) Number
- FDA Product Code
- CEM, JGS
- GMDN Term
- Potassium (K+) IVD, kit, ion-selective electrode (ISE)
- Device Class
- Class II
- Regulation Number
- 862.1600, 862.1665
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
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Properties
Other properties (12)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No