SECURE® - EMPTY EVA DUAL CHAMBER CONTAINER With Screw - METRIX COMPANY, THE

Duns Number:043046283

Device Description: EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors

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More Product Details

Catalog Number

66615

Brand Name

SECURE®

Version/Model Number

66615

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K960581,K960581

Product Code Details

Product Code

KPE

Product Code Name

Container, I.V.

Device Record Status

Public Device Record Key

dcee3dea-0a13-4685-9d6c-7bd5770ff4ca

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

50812496011461

Quantity per Package

42

Contains DI Package

00812496011466

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Carton

"METRIX COMPANY, THE" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 84