BD PosiFlush SureScrub - SYR 5ML SURESCRUB POSIFLUSH SALINE - BECTON, DICKINSON AND COMPANY

Duns Number:001292192

Device Description: SYR 5ML SURESCRUB POSIFLUSH SALINE

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More Product Details

Catalog Number

306558

Brand Name

BD PosiFlush SureScrub

Version/Model Number

306558

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

K121655,K121655,K121655

Product Code Details

Product Code

LKB

Product Code Name

Pad, alcohol, device disinfectant

Device Record Status

Public Device Record Key

32cbf0af-4d84-4013-9e82-8a08484c2cdc

Public Version Date

October 06, 2020

Public Version Number

5

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

50382903065580

Quantity per Package

16

Contains DI Package

30382903065586

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