Large CPAP Cap Only - Medicomp

Duns Number:154454730

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More Product Details

Catalog Number

MC-1212

Brand Name

Large CPAP Cap Only

Version/Model Number

MC-1212

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 16, 2020

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

CAT

Product Code Name

Cannula, Nasal, Oxygen

Device Record Status

Public Device Record Key

7baeebb9-db6f-4f8a-abbd-cbfd823fc71a

Public Version Date

September 17, 2020

Public Version Number

3

DI Record Publish Date

September 11, 2017

Additional Identifiers

Package DI Number

10858409005273

Quantity per Package

12

Contains DI Package

00858409005276

Package Discontinue Date

September 16, 2020

Package Status

Not in Commercial Distribution

Package Type

case

"MEDICOMP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 53
2 A medical device with a moderate to high risk that requires special controls. 5