External water supply module - Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Duns Number:654671304

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More Product Details

Catalog Number

-

Brand Name

External water supply module

Version/Model Number

115-005403-00

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

K160370

Product Code Details

Product Code

JGS

Product Code Name

ELECTRODE, ION SPECIFIC, SODIUM

Device Record Status

Public Device Record Key

a9264e1d-5b2a-4016-8de2-bd19cd385796

Public Version Date

September 16, 2022

Public Version Number

5

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