Caremed - Caremed NIBP Cuff - Shenzhen Caremed Medical Technology Co., Ltd.

Duns Number:544335718

Device Description: Caremed NIBP Cuff

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More Product Details

Catalog Number

N2S11-10

Brand Name

Caremed

Version/Model Number

N2S11-10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 2019

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

K182433

Product Code Details

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Device Record Status

Public Device Record Key

c9f50bbf-f73d-4a9c-a013-5680ce14988b

Public Version Date

November 11, 2019

Public Version Number

1

DI Record Publish Date

November 01, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22