WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER - SB-KAWASUMI LABORATORIES, INC.

Duns Number:690625850

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More Product Details

Catalog Number

-

Brand Name

WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER

Version/Model Number

DBM1-19G

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

6fa028a9-5ea0-43e7-bcd9-a811a8d07f89

Public Version Date

April 15, 2022

Public Version Number

6

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SB-KAWASUMI LABORATORIES, INC." 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. 211