Typenex Transport Tubes - Non Sterile Transport Tube - 5 ML - Caps Separate - TYPENEX MEDICAL LLC

Duns Number:600850213

Device Description: Non Sterile Transport Tube - 5 ML - Caps Separate

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More Product Details

Catalog Number

TC0101XNS

Brand Name

Typenex Transport Tubes

Version/Model Number

TC0101XNS

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

NNK

Product Code Name

Container, Specimen Mailer And Storage, Non-Sterile

Device Record Status

Public Device Record Key

c28cb230-8b2d-495d-a9c3-3d025cc6e26c

Public Version Date

August 19, 2020

Public Version Number

1

DI Record Publish Date

August 11, 2020

Additional Identifiers

Package DI Number

00810050852302

Quantity per Package

1000

Contains DI Package

00810050852319

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"TYPENEX MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 39
2 A medical device with a moderate to high risk that requires special controls. 48