OneCath - The OneCath Intermittent Urinary Catheter is a - COMPACTCATH, INC.

Duns Number:054765780

Device Description: The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.

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More Product Details

Catalog Number

1612 (30 pack)

Brand Name

OneCath

Version/Model Number

201-1612 (30)

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

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

EZD

Product Code Name

Catheter, Straight

Device Record Status

Public Device Record Key

3ceb6521-9d44-4670-9b92-739cc93f883c

Public Version Date

October 04, 2021

Public Version Number

1

DI Record Publish Date

September 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COMPACTCATH, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9