DISP ECG LW, 5LEAD, SNAP TO MULTI LINK - DISP ECG LW, 5LEAD, SNAP TO MULTI LINK - CURBELL MEDICAL PRODUCTS, INC.

Duns Number:796452311

Device Description: DISP ECG LW, 5LEAD, SNAP TO MULTI LINK

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More Product Details

Catalog Number

6759

Brand Name

DISP ECG LW, 5LEAD, SNAP TO MULTI LINK

Version/Model Number

DLW-05AD-40AM-0000

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

Yes

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

-

Product Code Details

Product Code

DSA

Product Code Name

Cable, Transducer And Electrode, Patient, (Including Connector)

Device Record Status

Public Device Record Key

d6571a9f-a0d0-4370-ad6f-ce82682e836c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

90840828100505

Quantity per Package

10

Contains DI Package

90840828100499

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CURBELL MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 478
2 A medical device with a moderate to high risk that requires special controls. 8062