Maveric Medical - Blood Collection Set, Safety, 21G x 3/4", 7" - MAVERIC MEDICAL LLC

Duns Number:117229530

Device Description: Blood Collection Set, Safety, 21G x 3/4", 7" Tubing, Preattached Holder

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More Product Details

Catalog Number

-

Brand Name

Maveric Medical

Version/Model Number

M6217

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 25, 2021

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

K172763,K172763,K172763

Product Code Details

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Device Record Status

Public Device Record Key

344c8ca6-efdd-4f25-bfc1-022516bf5567

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

July 29, 2021

Additional Identifiers

Package DI Number

10085002813169

Quantity per Package

25

Contains DI Package

00085002813162

Package Discontinue Date

September 25, 2021

Package Status

Not in Commercial Distribution

Package Type

Box

"MAVERIC MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6