TUBE,NIBP,ADU/PED/INF,CONN,3M - Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Duns Number:654671304

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More Product Details

Catalog Number

-

Brand Name

TUBE,NIBP,ADU/PED/INF,CONN,3M

Version/Model Number

6200-30-09688

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)

-

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

K132038

Product Code Details

Product Code

MWI

Product Code Name

MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Device Record Status

Public Device Record Key

aeb0573c-d4ff-4ef0-8ef4-db68eb45c3c4

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 1079