Catalog Number

70055

Brand Name

ReliOn Ultima

Version/Model Number

70055

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"

-

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

K083223,K083223

Product Code

JJX

Product Code Name

Single (specified) analyte controls (assayed and unassayed)

Public Device Record Key

2cd7ff8b-703f-4d1e-8469-a704c83f9116

Public Version Date

February 26, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

30681131060289

Quantity per Package

4

Contains DI Package

00681131060288

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case