Lumex - PATIENT LIFT FPETAL BLK-SLVR - GF HEALTH PRODUCTS, INC.

Duns Number:132016168

Device Description: PATIENT LIFT FPETAL BLK-SLVR

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

LF1031FP

Brand Name

Lumex

Version/Model Number

LF1031FP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

FSA

Product Code Name

Lift, Patient, Non-Ac-Powered

Device Record Status

Public Device Record Key

35742b94-0546-4ac5-a49f-2894fcfe961f

Public Version Date

November 23, 2021

Public Version Number

2

DI Record Publish Date

October 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GF HEALTH PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1068
2 A medical device with a moderate to high risk that requires special controls. 202