Aretech Premium Harness - Size: Pediatric (waist circumference measured 2" - ARETECH, LLC

Duns Number:825904738

Device Description: Size: Pediatric (waist circumference measured 2" below belly button: 22 - 26 inches). The Size: Pediatric (waist circumference measured 2" below belly button: 22 - 26 inches). The Aretech Premium Harness is designed for use with Aretech products.

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More Product Details

Catalog Number

-

Brand Name

Aretech Premium Harness

Version/Model Number

AH-0P

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

IKX

Product Code Name

Aid, Transfer

Device Record Status

Public Device Record Key

56fe3a14-c30e-43c2-a544-855b9ca6f95c

Public Version Date

October 04, 2021

Public Version Number

1

DI Record Publish Date

September 24, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARETECH, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14