Blood Pressure Meter - The Blood Pressure Meter is a manual non-invasive - Wenzhou Renhua Instruments Co.,Ltd

Duns Number:541055663

Device Description: The Blood Pressure Meter is a manual non-invasive aneroid sphygmomanometer which respectiv The Blood Pressure Meter is a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories include additional stethoscope. It is conjunction with Stethoscope when use.

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More Product Details

Catalog Number

-

Brand Name

Blood Pressure Meter

Version/Model Number

Model Max0203 (Blue, Pink or Black cuff)

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190902

Product Code Details

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Device Record Status

Public Device Record Key

2c8cc7fe-f415-47d0-b6e1-15768af158dd

Public Version Date

July 22, 2019

Public Version Number

1

DI Record Publish Date

July 12, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WENZHOU RENHUA INSTRUMENTS CO.,LTD" 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. 4