6995 ANASTHESIA FACE MASK - PED SM ANESTHESIA FACE MASK - HANS RUDOLPH, INC.

Duns Number:007131725

Device Description: PED SM ANESTHESIA FACE MASK

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More Product Details

Catalog Number

669078

Brand Name

6995 ANASTHESIA FACE MASK

Version/Model Number

6995

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

BSJ

Product Code Name

Mask, Gas, Anesthetic

Device Record Status

Public Device Record Key

9f7e865a-00e0-4481-8df9-29072373e418

Public Version Date

December 10, 2018

Public Version Number

1

DI Record Publish Date

November 07, 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