Catalog Number

-

Brand Name

FLUID MANAGEMENT PACK

Version/Model Number

C020500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

NWW

Product Code Name

Hysteroscope Accessories

Public Device Record Key

2aec1ea4-4dd7-45d0-b61e-dbb879be8e18

Public Version Date

October 31, 2019

Public Version Number

1

DI Record Publish Date

October 23, 2019

Package DI Number

M648C0502001

Quantity per Package

5

Contains DI Package

M648C0502000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX