Nonin - Xpod LP with 600CA, 7000A for use with GE Apex - NONIN MEDICAL, INC.

Duns Number:174959692

Device Description: Xpod LP with 600CA, 7000A for use with GE Apex Pro FH

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More Product Details

Catalog Number

-

Brand Name

Nonin

Version/Model Number

3013FH

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K093853,K093853

Product Code Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

3225cd13-b2f8-44e1-9cdf-b6a660fc7ad6

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

August 24, 2016

Additional Identifiers

Package DI Number

00833166001280

Quantity per Package

1

Contains DI Package

00833166001259

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"NONIN MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 130