CliniCare 10P - The passive mattres is the foam mattress intended - L I N E T spol. s r.o.

Duns Number:644544504

Device Description: The passive mattres is the foam mattress intended for medical bed.

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More Product Details

Catalog Number

-

Brand Name

CliniCare 10P

Version/Model Number

4PPKP1100AS

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

06f29e73-d3c2-4caa-afa7-5628453139f4

Public Version Date

August 27, 2018

Public Version Number

1

DI Record Publish Date

July 27, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"L I N E T SPOL. S R.O." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 196