7450 - 7450 S FACE MASK-HDGR 22MM ID - HANS RUDOLPH, INC.

Duns Number:007131725

Device Description: 7450 S FACE MASK-HDGR 22MM ID

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More Product Details

Catalog Number

201806

Brand Name

7450

Version/Model Number

7450

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"

-

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

KGB

Product Code Name

Mask, Oxygen, Non-Rebreathing

Device Record Status

Public Device Record Key

635d9cb9-a20a-419d-a50e-c8a323665b76

Public Version Date

December 10, 2018

Public Version Number

1

DI Record Publish Date

November 08, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HANS RUDOLPH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 922
2 A medical device with a moderate to high risk that requires special controls. 407