Ambu AuraStraight Silicone #5 - Ambu AuraStraight Silicone #5 qty:10 - BESMED HEALTH BUSINESS CORP.

Duns Number:658023775

Device Description: Ambu AuraStraight Silicone #5 qty:10

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More Product Details

Catalog Number

-

Brand Name

Ambu AuraStraight Silicone #5

Version/Model Number

342500000

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)

-

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

7d7d9ac0-33c5-4288-9bcd-89a6d89853d4

Public Version Date

August 14, 2019

Public Version Number

1

DI Record Publish Date

August 06, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BESMED HEALTH BUSINESS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 289
2 A medical device with a moderate to high risk that requires special controls. 217