PRIMO/ASP MEDICAL - Wipe Down Cushion (16" x 18" x 4.5") - Asp Global, LLC

Duns Number:080361159

Device Description: Wipe Down Cushion (16" x 18" x 4.5")

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More Product Details

Catalog Number

-

Brand Name

PRIMO/ASP MEDICAL

Version/Model Number

DUPC1618

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

IMP

Product Code Name

Cushion, Wheelchair

Device Record Status

Public Device Record Key

8cda7c28-4ff7-4884-8fdb-eda1532102c0

Public Version Date

August 31, 2022

Public Version Number

1

DI Record Publish Date

August 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASP GLOBAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1046
2 A medical device with a moderate to high risk that requires special controls. 23
U Unclassified 2