C1 Cleaning Solution - For use as a cleaning solution on the Polychem - Medtest Dx, Inc.

Duns Number:070371210

Device Description: For use as a cleaning solution on the Polychem 180 System. Concentrate formula. Use accor For use as a cleaning solution on the Polychem 180 System. Concentrate formula. Use according to package instructions. 6 x 10 ml

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More Product Details

Catalog Number

C1S500

Brand Name

C1 Cleaning Solution

Version/Model Number

C1S500

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)

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

6b21c42d-37c1-4fc4-bb52-9edf42f0547a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 27, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTEST DX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38
2 A medical device with a moderate to high risk that requires special controls. 33