Catalog Number

V11440-512

Brand Name

NOVAPLUS

Version/Model Number

V11440-512

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IMD

Product Code Name

PACK, HOT OR COLD, DISPOSABLE

Public Device Record Key

5b51992e-e5fa-42e4-bb0a-9722fee46fcb

Public Version Date

May 20, 2019

Public Version Number

1

DI Record Publish Date

May 10, 2019

Package DI Number

50885380057487

Quantity per Package

4

Contains DI Package

20885380057486

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE