Fall Guardian - Fall Guardian Economy Monitor with bed pad case - Smart Caregiver Corporation

Duns Number:012082397

Device Description: Fall Guardian Economy Monitor with bed pad case

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More Product Details

Catalog Number

-

Brand Name

Fall Guardian

Version/Model Number

FG2B45R-SYS/CS

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

KMI

Product Code Name

Monitor, Bed Patient

Device Record Status

Public Device Record Key

7723fb46-d17e-4fef-9d99-a14f82955027

Public Version Date

July 27, 2022

Public Version Number

1

DI Record Publish Date

July 19, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMART CAREGIVER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 510