MediChoice - Airway Berman Satin-Smooth Finish Individually - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: Airway Berman Satin-Smooth Finish Individually Bagged Polypropylene 50 Millimeter Non-Ster Airway Berman Satin-Smooth Finish Individually Bagged Polypropylene 50 Millimeter Non-Sterile Not Made With Natural Rubber Latex MediChoice

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More Product Details

Catalog Number

-

Brand Name

MediChoice

Version/Model Number

BA5050

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

-

Product Code Details

Product Code

CAE

Product Code Name

AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Device Record Status

Public Device Record Key

ee33ec6b-ce34-402e-a463-db833ca69067

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Additional Identifiers

Package DI Number

50885632102231

Quantity per Package

5

Contains DI Package

20885632102230

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"OWENS & MINOR DISTRIBUTION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 428
2 A medical device with a moderate to high risk that requires special controls. 8754
U Unclassified 1