Catalog Number

-

Brand Name

Healthline Medical Inc. - Medicator Maximixer+Plus-Accessories

Version/Model Number

AM-608P

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"

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

-

Product Code

BSJ

Product Code Name

Mask, Gas, Anesthetic

Public Device Record Key

59d79b4f-973b-493c-a71a-8419fc1a4e19

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

November 09, 2020

Package DI Number

00850022357497

Quantity per Package

10

Contains DI Package

00850022357053

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-