MRV6000LD - Therapeutic Phlebotomy Bag w/Needle - 500 mL Phlebotomy Bag with Needle. - MACO PRODUCTIONS

Duns Number:265492868

Device Description: 500 mL Phlebotomy Bag with Needle.

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More Product Details

Catalog Number

MRV6000LD

Brand Name

MRV6000LD - Therapeutic Phlebotomy Bag w/Needle

Version/Model Number

MRV

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 02, 2019

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

BK030008,BK030008

Product Code Details

Product Code

CAK

Product Code Name

Microfilter, Blood Transfusion

Device Record Status

Public Device Record Key

a93ed5a4-c757-4d4d-ba7a-99e108569f7a

Public Version Date

November 04, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

13567051503125

Quantity per Package

20

Contains DI Package

03567051503128

Package Discontinue Date

November 02, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton

"MACO PRODUCTIONS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 9