Healthline Medical Products - PVC Shower Gurney - Healthline Medical Products Inc

Duns Number:835917212

Device Description: PVC Shower Gurney

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More Product Details

Catalog Number

ABSG200W5

Brand Name

Healthline Medical Products

Version/Model Number

ABSG200W5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 10, 2025

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

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

FPO

Product Code Name

Stretcher, Wheeled

Device Record Status

Public Device Record Key

525384c8-e76b-4e2c-8d90-6fbd6766fc1d

Public Version Date

March 26, 2021

Public Version Number

1

DI Record Publish Date

March 18, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEALTHLINE MEDICAL PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2