E-LINK CA1 Battery Charger - Mains powered battery charging unit for up to 4 - BIOMETRICS LIMITED

Duns Number:519969810

Device Description: Mains powered battery charging unit for up to 4 wireless E-LINK sensors (GX5, NC6, AD1). I Mains powered battery charging unit for up to 4 wireless E-LINK sensors (GX5, NC6, AD1). Includes Medical Grade Power Supply and country specific mains power cord..This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013

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More Product Details

Catalog Number

-

Brand Name

E-LINK CA1 Battery Charger

Version/Model Number

CA1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

BXB

Product Code Name

Exerciser, Powered

Device Record Status

Public Device Record Key

49054bcf-1225-4ae8-a3e4-5a8cbdc502b0

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

August 09, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMETRICS LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 27
2 A medical device with a moderate to high risk that requires special controls. 25