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Alexander Mfg. Co. Rechargeable Battery Part Number M212

by Alexander Mfg. Co.

510(k) K972084

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972084 Date3 Jul 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Alexander Manufacturing Co. Rechargeable Battery Part Number M212
510(k) Number
FDA Product Code
FLN
Device Class
Class II
Regulation
21 CFR Part 880.2420
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Alexander Mfg. Co. Rechargeable Battery Part Number M212 is a rechargeable battery device classified as a Monitor, Electric For Gravity Flow Infusion Systems. It is intended for use in infusion systems that rely on gravity flow.

The device is supplied as a single-use item and is not sterilized. It is not MRI safe. The device is regulated under FDA 510(k) clearance and is classified as Class II with Special Controls. It is stored at room temperature.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Alexander Mfg. Co. Rechargeable Battery M212 used for?

    It is intended for use in infusion systems that rely on gravity flow, providing power as a Monitor, Electric For Gravity Flow Infusion Systems, as specified in its device classification and description.

  • Is the Alexander Mfg. Co. Rechargeable Battery M212 sterile or single-use?

    The device is supplied as a single-use item and is not sterilized, meaning it is designed for one-time use and should not be reprocessed or reused after initial deployment.

  • How should the Alexander Mfg. Co. Rechargeable Battery M212 be stored?

    The device is stored at room temperature, as indicated in the storage instructions provided in the device data, with no special environmental controls required.

  • Is the Alexander Mfg. Co. Rechargeable Battery M212 safe for use in MRI environments?

    The device is not MRI safe, as explicitly stated in the device data, so it should not be brought into or used near magnetic resonance imaging equipment due to potential safety risks.