Care Touch - Syringes Luer Lock 5ml - FUTURE DIAGNOSTICS LLC

Duns Number:080113296

Device Description: Syringes Luer Lock 5ml

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More Product Details

Catalog Number

-

Brand Name

Care Touch

Version/Model Number

LLS5ml

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

710b2511-b6ff-4892-9522-6536a5cf6844

Public Version Date

June 17, 2019

Public Version Number

4

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

10370393519012

Quantity per Package

6

Contains DI Package

00370393519015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"FUTURE DIAGNOSTICS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 5