Aero-Med - Blood Culture Collection Kit, Steripath Gen 2, - Aero-Med, Ltd.

Duns Number:194550042

Device Description: Blood Culture Collection Kit, Steripath Gen 2, 21G, Kettering Medical Center Only

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More Product Details

Catalog Number

CA21300

Brand Name

Aero-Med

Version/Model Number

CA21300

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

OIB

Product Code Name

Blood and urine collection kit (excludes HIV testing)

Device Record Status

Public Device Record Key

07e11ac9-d0b2-41cd-a491-0bbfbcf182da

Public Version Date

July 10, 2019

Public Version Number

1

DI Record Publish Date

July 02, 2019

Additional Identifiers

Package DI Number

50885380173613

Quantity per Package

25

Contains DI Package

10885380173615

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