McKesson - Non-Rebreather Mask ADULT, HIGH CONCENTRATION, - MCKESSON MEDICAL-SURGICAL INC.

Duns Number:023904428

Device Description: Non-Rebreather Mask ADULT, HIGH CONCENTRATION, 360° SWIVEL INTERFACE 7’ (2.1 m) CRUSH RESI Non-Rebreather Mask ADULT, HIGH CONCENTRATION, 360° SWIVEL INTERFACE 7’ (2.1 m) CRUSH RESISTANT TUBING WITH UNIVERSAL CONNECTOR SAFETY VALVE SINGLE PATIENT USE

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More Product Details

Catalog Number

-

Brand Name

McKesson

Version/Model Number

32634

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

BYG

Product Code Name

Mask, Oxygen

Device Record Status

Public Device Record Key

b6c0d9aa-c18c-4035-8f55-60a0b6e977b4

Public Version Date

July 29, 2020

Public Version Number

1

DI Record Publish Date

July 21, 2020

Additional Identifiers

Package DI Number

40612479208351

Quantity per Package

50

Contains DI Package

20612479208340

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MCKESSON MEDICAL-SURGICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 870
2 A medical device with a moderate to high risk that requires special controls. 422
U Unclassified 44