AIV - CB10639 - Pulse Oximeter Adapter Cable - AMERICAN IV PRODUCTS, INC.

Duns Number:181184474

Device Description: CB10639 - Pulse Oximeter Adapter Cable

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More Product Details

Catalog Number

CB10639

Brand Name

AIV

Version/Model Number

CB10639

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2019

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"

-

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

-

Product Code Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

14f4a677-c617-4cfc-8639-9f44528f9c16

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

September 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMERICAN IV PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24