Albahealth - 3X-LARGE-REGULAR THIGH - Albahealth, LLC

Duns Number:003375805

Device Description: 3X-LARGE-REGULAR THIGH

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More Product Details

Catalog Number

-

Brand Name

Albahealth

Version/Model Number

000468062100304

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"

Yes

For Single-Use

Yes

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

DWL

Product Code Name

Stocking, medical support (to prevent pooling of blood in legs)

Device Record Status

Public Device Record Key

848020a9-6c7b-426d-b683-839996ba7cf5

Public Version Date

July 07, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

50073614793557

Quantity per Package

12

Contains DI Package

00073614793552

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ALBAHEALTH, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 300