Durable CPCP slim tube - 6' - Durable CPCP slim tube - 6' - BLEEP, LLC

Duns Number:081909526

Device Description: Durable CPCP slim tube - 6'

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More Product Details

Catalog Number

-

Brand Name

Durable CPCP slim tube - 6'

Version/Model Number

TUB006SS

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

K172335

Product Code Details

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Device Record Status

Public Device Record Key

ab02ecc1-db20-4625-9efb-9a394e049180

Public Version Date

August 31, 2022

Public Version Number

1

DI Record Publish Date

August 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BLEEP, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16