QUICK-DRAW PLAIN ADAPTER - QUICK-DRAW PLAIN ADAPTER FOR USE WITH INNOVAC - INNOVATIVE MEDICAL TECHNOLOGIES, INC

Duns Number:792740578

Device Description: QUICK-DRAW PLAIN ADAPTER FOR USE WITH INNOVAC

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More Product Details

Catalog Number

-

Brand Name

QUICK-DRAW PLAIN ADAPTER

Version/Model Number

15-900

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

K972969,K972969,K972969

Product Code Details

Product Code

GIO

Product Code Name

Tube, Collection, Capillary Blood

Device Record Status

Public Device Record Key

845d7da4-ad95-4a39-b5a6-ea4fe4fee05b

Public Version Date

August 09, 2018

Public Version Number

4

DI Record Publish Date

August 05, 2016

Additional Identifiers

Package DI Number

20857182006085

Quantity per Package

5

Contains DI Package

10857182006088

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"INNOVATIVE MEDICAL TECHNOLOGIES, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1