Alexander Manufacturing Battery Part Number MC146X
510(k) K981776
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK981776 | Date3 Aug 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Alexander Manufacturing Co. Battery Part Number MC146X
- 510(k) Number
- FDA Product Code
- FRN
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Alexander Manufacturing Battery Part Number MC146X is a pump, infusion device, as classified under FDA product code FRN. It serves as a power source for infusion pumps, providing the necessary electrical energy to operate volumetric infusion systems in clinical settings. This battery consists of six mercuric oxide cells, delivering a nominal voltage of 8.4 volts to drive infusion functions.
This battery is intended for use in general hospital environments as a reusable component for infusion pumps. It is supplied as a standalone power unit, requiring no additional sterilization beyond standard hospital cleaning protocols. The device is classified as Class II under FDA regulations and holds a 510(k) clearance (K981776) for substantial equivalence to comparable infusion pump batteries. Storage and handling follow standard electrical device guidelines, ensuring compatibility with infusion systems in MRI-safe zones when used as intended.
Other devices from Alexander Mfg. Co.
Questions
AI-generated answers, 1 Oct 2026
What is the Alexander Manufacturing Battery Part Number MC146X used for?
The Alexander Manufacturing Battery Part Number MC146X is designed as a power source for infusion pumps. It provides the necessary electrical energy (8.4 volts) to operate volumetric infusion systems in clinical environments, ensuring reliable function for administering fluids and medications in general hospital settings.
How is the MC146X battery supplied and prepared for use?
The MC146X battery is supplied as a standalone, reusable component for infusion pumps. It does not require additional sterilization beyond standard hospital cleaning protocols, which means it can be cleaned and reused as part of routine maintenance procedures for infusion systems.
Is the MC146X battery single-use or reusable?
The MC146X battery is classified as a reusable component. It is intended to be integrated into infusion pump systems and cleaned according to standard hospital protocols rather than being discarded after a single use.
What type of battery cells does the MC146X use, and what voltage does it provide?
The MC146X battery consists of six mercuric oxide cells, delivering a nominal voltage of 8.4 volts. This voltage output is specifically designed to power volumetric infusion systems in clinical settings.
How should the MC146X battery be stored and handled?
The MC146X battery should be stored and handled following standard electrical device guidelines. This ensures compatibility with infusion systems, including use in MRI-safe zones when used as intended. Proper storage conditions help maintain its functionality and safety for clinical applications.