BEMIS - 1 QUART RED PHLEBOTOMY CONTAINER - Bemis de México, S.A. de C.V.

Duns Number:589153555

Device Description: 1 QUART RED PHLEBOTOMY CONTAINER

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More Product Details

Catalog Number

100 030

Brand Name

BEMIS

Version/Model Number

100 030

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K960525,K960525

Product Code Details

Product Code

MMK

Product Code Name

Container, Sharps

Device Record Status

Public Device Record Key

ed8f26b4-2fbb-42ff-915f-3d5d45781413

Public Version Date

September 18, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BEMIS DE MÉXICO, S.A. DE C.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4