CMATT - INSTITUTIONAL MATTRESS W/ INTEGRATED PILLOW, 4 X - CASCO MANUFACTURING SOLUTIONS, INC.

Duns Number:004253936

Device Description: INSTITUTIONAL MATTRESS W/ INTEGRATED PILLOW, 4 X 30 X 75, 12OZ. DENSIFIED POLYESTER CORE, INSTITUTIONAL MATTRESS W/ INTEGRATED PILLOW, 4 X 30 X 75, 12OZ. DENSIFIED POLYESTER CORE, CLEAR/OPAQUE VINYL COVER

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More Product Details

Catalog Number

H10407

Brand Name

CMATT

Version/Model Number

H10407

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

IKY

Product Code Name

Mattress, Flotation Therapy, Non-Powered

Device Record Status

Public Device Record Key

95eb4ac3-5070-4168-8eed-0cbf87b4310c

Public Version Date

October 12, 2021

Public Version Number

1

DI Record Publish Date

October 04, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CASCO MANUFACTURING SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 849
2 A medical device with a moderate to high risk that requires special controls. 1