Aero-Med - Pathology Specimen Transport Kit, Medical Center - Aero-Med, Ltd.

Duns Number:194550042

Device Description: Pathology Specimen Transport Kit, Medical Center of Wisconsin Only

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More Product Details

Catalog Number

CA29050

Brand Name

Aero-Med

Version/Model Number

CA29050

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)

Yes

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

79fa3bf2-b0b9-499f-886b-955cf0cc05cf

Public Version Date

March 22, 2021

Public Version Number

1

DI Record Publish Date

March 13, 2021

Additional Identifiers

Package DI Number

50885380177611

Quantity per Package

20

Contains DI Package

10885380177613

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"AERO-MED, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 467
2 A medical device with a moderate to high risk that requires special controls. 14