NA - F2 Non-Vented Full Face Mask Replacement Headgear - BMC Medical Co., Ltd.

Duns Number:526010310

Device Description: F2 Non-Vented Full Face Mask Replacement Headgear

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

NA

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

e3d8970c-3ef8-436b-a597-6a9b3892832e

Public Version Date

May 23, 2018

Public Version Number

3

DI Record Publish Date

November 15, 2017

Additional Identifiers

Package DI Number

16948538362126

Quantity per Package

60

Contains DI Package

06948538362129

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BMC MEDICAL CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 90