Alpha - OTM1 Mattress - INSPIRATION HEALTHCARE GROUP PLC

Duns Number:235903494

Device Description: OTM1 Mattress

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More Product Details

Catalog Number

-

Brand Name

Alpha

Version/Model Number

OTM1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

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

DWJ

Product Code Name

System, thermal regulating

Device Record Status

Public Device Record Key

4d87a339-d286-4392-bc8a-a3453718ac5e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INSPIRATION HEALTHCARE GROUP PLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 88