Wide Range D-Ring Cuff 9" to 17" - Contoured wide range Blood Pressure Cuff 9" to 17" - Omron Healthcare, Inc.

Duns Number:054318779

Device Description: Contoured wide range Blood Pressure Cuff 9" to 17"

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More Product Details

Catalog Number

CD-WR17

Brand Name

Wide Range D-Ring Cuff 9" to 17"

Version/Model Number

CD-WR17

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K133379,K133379

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

3cc8a653-56cc-4268-8a94-644e10225aa5

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

10073796343177

Quantity per Package

20

Contains DI Package

00073796343170

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"OMRON HEALTHCARE, INC." 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. 48