NAMIC - NAMIC Convenience Kit - NAVILYST MEDICAL, INC.

Duns Number:809699023

Device Description: NAMIC Convenience Kit

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More Product Details

Catalog Number

-

Brand Name

NAMIC

Version/Model Number

PK232023S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

4625c23d-ece1-4fb9-9ed2-74a8b170859f

Public Version Date

October 08, 2018

Public Version Number

1

DI Record Publish Date

September 06, 2018

Additional Identifiers

Package DI Number

H965PK232023S1

Quantity per Package

10

Contains DI Package

H965PK232023S0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"NAVILYST MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 71
2 A medical device with a moderate to high risk that requires special controls. 1641