SHIPPING SYSTEM - Shipping System, Trasis without Syringes - BIODEX MEDICAL SYSTEMS, INC.

Duns Number:043833813

Device Description: Shipping System, Trasis without Syringes

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More Product Details

Catalog Number

001-692

Brand Name

SHIPPING SYSTEM

Version/Model Number

001-692

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

-

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

KPY

Product Code Name

Shield, Protective, Personnel

Device Record Status

Public Device Record Key

3cdb40ac-6ff4-48d9-a16d-30248c99569f

Public Version Date

March 30, 2020

Public Version Number

2

DI Record Publish Date

March 29, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIODEX MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 193
2 A medical device with a moderate to high risk that requires special controls. 52