RELI® - Reli Gem Safety Blood Collection Set 21G x 3/4", - MYCO MEDICAL SUPPLIES INC.

Duns Number:879187821

Device Description: Reli Gem Safety Blood Collection Set 21G x 3/4", 3" tubing with tube holder

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More Product Details

Catalog Number

GSBCS21G-3T

Brand Name

RELI®

Version/Model Number

GSBCS21G-3T

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

K170276,K170276,K170276

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

b2e3419f-f9fa-4a2e-8306-9c7af98a81f9

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

October 26, 2018

Additional Identifiers

Package DI Number

20386120008756

Quantity per Package

8

Contains DI Package

10386120008759

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MYCO MEDICAL SUPPLIES INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 471