ITD - Flexion Monitor Holder w/ Cover for Pro-cart - Touchpoint Medical, Inc.

Duns Number:080434935

Device Description: Flexion Monitor Holder w/ Cover for Pro-cart column

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More Product Details

Catalog Number

-

Brand Name

ITD

Version/Model Number

CD.45018.800

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"

Yes

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

BZN

Product Code Name

Cart, Emergency, Cardiopulmonary (Excluding Equipment)

Device Record Status

Public Device Record Key

483b847b-9ef5-45b0-b0a6-0cc7c0200b51

Public Version Date

August 26, 2022

Public Version Number

1

DI Record Publish Date

August 18, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TOUCHPOINT MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 153