Healthline, Medicator Maximizer Plus - Medicator Maximizer+Plus Neb3A - Medi/Nuclear Corporation, Inc.

Duns Number:079628327

Device Description: Medicator Maximizer+Plus Neb3A

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More Product Details

Catalog Number

-

Brand Name

Healthline, Medicator Maximizer Plus

Version/Model Number

AM-602

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

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

K960397,K960397

Product Code Details

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Device Record Status

Public Device Record Key

2bcbe6be-1ce6-46be-a5d6-54556a1b58f1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 09, 2017

Additional Identifiers

Package DI Number

00857863007796

Quantity per Package

10

Contains DI Package

00857863007710

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"MEDI/NUCLEAR CORPORATION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 90