Unimed - ECG Monitor Lead WirePhilips Philips - Unimed Medical Supplies, Inc.

Duns Number:527971025

Device Description: ECG Monitor Lead WirePhilips Philips

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More Product Details

Catalog Number

-

Brand Name

Unimed

Version/Model Number

PPT6-90P

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

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

0320e35b-5530-47de-aebf-98739cf28d0a

Public Version Date

October 04, 2022

Public Version Number

1

DI Record Publish Date

September 26, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"UNIMED MEDICAL SUPPLIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 9415