QT ECG - PCA-C100BL Patient Cable is intended to be used - QT MEDICAL, INC.

Duns Number:078875059

Device Description: PCA-C100BL Patient Cable is intended to be used with QT ECG device. The Patient Cable is u

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More Product Details

Catalog Number

-

Brand Name

QT ECG

Version/Model Number

PCA-C100BL

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"

Yes

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

K200722

Product Code Details

Product Code

DSA

Product Code Name

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

Device Record Status

Public Device Record Key

eb7ab71e-8dfa-4fa7-af74-4ce7c48e4f0d

Public Version Date

August 04, 2022

Public Version Number

1

DI Record Publish Date

July 27, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QT MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 18