CMATT - PREVENTION REPLACEMENT CRIB MATTRESS H12600-P, W - CASCO MANUFACTURING SOLUTIONS, INC.

Duns Number:004253936

Device Description: PREVENTION REPLACEMENT CRIB MATTRESS H12600-P, W POLYCARBONATE COVER, 3 X 22 X 33, CAL 129 PREVENTION REPLACEMENT CRIB MATTRESS H12600-P, W POLYCARBONATE COVER, 3 X 22 X 33, CAL 129/FED 1633

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More Product Details

Catalog Number

H12600-P

Brand Name

CMATT

Version/Model Number

H12600

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

35670ca4-c469-46ef-81cc-5ad0a6ff4e4e

Public Version Date

September 16, 2020

Public Version Number

2

DI Record Publish Date

September 03, 2020

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