PERSONAL TRANSPORT STRETCHER W/OVERSIZED BED SURFACE 31" WITH HEAD REST - PERSONAL TRANSPORT STRETCHER W/OVERSIZED BED - M.A.C. MEDICAL INC.

Duns Number:188660844

Device Description: PERSONAL TRANSPORT STRETCHER W/OVERSIZED BED SURFACE 31" WITH HEAD REST

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More Product Details

Catalog Number

PT2000-31-EYE

Brand Name

PERSONAL TRANSPORT STRETCHER W/OVERSIZED BED SURFACE 31" WITH HEAD REST

Version/Model Number

PT2000-31-EYE

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

FPO

Product Code Name

Stretcher, Wheeled

Device Record Status

Public Device Record Key

c3a8f706-863a-4e6a-8d11-6d9619e2f5cc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"M.A.C. MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 456
2 A medical device with a moderate to high risk that requires special controls. 32