Custom Medical Specialties, Inc. - Fluid Control System - Non-Sterile - CUSTOM ASSEMBLIES, INC.

Duns Number:948904735

Device Description: Fluid Control System - Non-Sterile

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More Product Details

Catalog Number

-

Brand Name

Custom Medical Specialties, Inc.

Version/Model Number

CMS-1222

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"

Yes

For Single-Use

Yes

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

BYY

Product Code Name

Tube, Aspirating, Flexible, Connecting

Device Record Status

Public Device Record Key

e2f30db9-3bb5-4835-819a-4e0cb36a267c

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

December 07, 2016

Additional Identifiers

Package DI Number

00815849020641

Quantity per Package

100

Contains DI Package

00815849020061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CUSTOM ASSEMBLIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 78
2 A medical device with a moderate to high risk that requires special controls. 72