Catalog Number

-

Brand Name

Analytical Industries Inc.

Version/Model Number

PSR-11-55-HL

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

-

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

K952736

Product Code

CCL

Product Code Name

ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Public Device Record Key

98594c25-b57e-485c-9570-2048c1ea68bf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-