BD Luer-Lok - SYRINGE 5ML LL TIP BULK CONVENIENCE PAK - BECTON, DICKINSON AND COMPANY

Duns Number:001292192

Device Description: SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

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More Product Details

Catalog Number

309703

Brand Name

BD Luer-Lok

Version/Model Number

309703

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K110771,K110771,K110771

Product Code Details

Product Code

FMF

Product Code Name

Syringe, piston

Device Record Status

Public Device Record Key

6ab9d7e5-cb75-45f3-8403-286e43c98c9a

Public Version Date

October 01, 2018

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

50382903097031

Quantity per Package

12

Contains DI Package

30382903097037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"BECTON, DICKINSON AND COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 611
2 A medical device with a moderate to high risk that requires special controls. 614
3 A medical device with high risk that requires premarket approval 36
U Unclassified 4