Apex Lifts - C-HLA-2 W/MESH LG U-SLING W/O HD SUPPORT - JOERNS HEALTHCARE, LLC

Duns Number:790937150

Device Description: C-HLA-2 W/MESH LG U-SLING W/O HD SUPPORT

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More Product Details

Catalog Number

C-HLA-2-50021

Brand Name

Apex Lifts

Version/Model Number

C-HLA-2-50021

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

FSA

Product Code Name

Lift, Patient, Non-Ac-Powered

Device Record Status

Public Device Record Key

3a8c7283-db7e-42ce-a79f-d9b115f61ac9

Public Version Date

December 23, 2021

Public Version Number

1

DI Record Publish Date

December 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JOERNS HEALTHCARE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 164
2 A medical device with a moderate to high risk that requires special controls. 131